How to Apply:

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to hr@origenbio.com.   Unfortunately, due to the volume of candidates, it is not possible to follow-up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

Current Job Openings:

Buyer / Planner

Position Summary

The Buyer/Planner will perform and manage plant supply chain activities. Ensure the continuous supply of high quality, low cost raw materials efficiently to keep daily operations running, while maintaining and reporting metrics that allow us to evaluate the performance of our suppliers. Confirm materials and capacity, plan and schedule production work orders to meet master schedule requirements. Manage inventory levels of raw material and work in process and manage inbound and outbound logistics.

Essential Duties and Responsibilities

  • Review and analyze weekly requirements generated by Epicor to determine what materials should be purchased.
  • Generate and track purchase orders for raw materials in order to ensure on time delivery.
  • Review and determine the availability of materials and capacity to meet the schedule in order to ensure that the production of final products meets customer needs.
  • Verify the availability of materials, weekly, relative to the production plan and make necessary adjustments to the weekly build schedule.
  • Manage inbound and outbound logistics to optimize the lead time, transportation costs, customs and regulatory clearances.
  • Evaluate Supplier Quality (in conjunction with Quality Assurance Engineer) and Delivery Performance and provide feedback to the supply base.
  • Work with the supply base to ensure timely delivery of supplier documentation (invoices, CoCs, etc.) to ensure a smooth flow of goods through the logistics pipeline as well as Incoming Quality Assurance.
  • Manage the return of rejected products with the supply base and follow up to receive the credit for the returned product.
  • Review and approve change orders in order to determine the impact of changes on material in the warehouse, on order and work in process. Work to minimize obsolescence.
  • Maintain MRP data in Epicor to ensure that the Epicor requirements correctly generate new raw material purchases.
  • Drive improvements in quality, cost and delivery of supplied components.
  • Coordinate the inspection of first articles when needed.
  • Resolve inventory discrepancies as appropriate.
  • Comply with all requirements, duties and obligations of our Quality Management System.
  • Comply with healthy and safety initiatives, policies and procedures. Identify opportunities to improve health and safety.
  • Safeguard all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their area of ​​work.

Required Skill Sets

  • Must be proficient on computer, possessing intermediate/ advanced navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment

Preferred Qualifications

  • B.S. or Masters degree in Engineering or Business Administration. At least 7 years of supply chain experience. At least 5 years experience in purchasing and production planning.
  • APICS CPIM certification. Experience in logistics and warehouse operations. Medical device experience preferred.
  • Knowledge and use of Epicor.

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”. Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
  • Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
  • Note: OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility. There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period.

Physical Demands and Work Environment 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience.

IT Engineer

Position Summary

The IT Engineer is responsible for maintaining and upgrading computer hardware and software systems.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Provides User support on hardware and software
  • Does Network repairs, upgrades and troubleshooting
  • Technical writing
  • Work in a highly regulated industry
  • Administration and support of Salesforce platform and Epicor ERP system
  • Administration and maintenance of Windows Active Directory and SQL Server
  • Creation and support of reports in SQL Server Reporting Services
  • Provides support for site security policies and processes, including but not limited to developing policies for successful implementation across the business (both physical and cyber-security)

Competencies

  • Experience with SQL databases
  • Good interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Computer Science/Math/Engineering
  • Ability to understand and interpret customer needs; ability to work with all departments (i.e. Regulatory, Operations, Human Resources, Engineering)
  • Ability to work independently and lead in a team environment

Preferred Qualifications

  • Experience with Epicor ERP software suite

Supervisory Responsibility

This position has no direct supervision. The individual may also be required to lead project teams and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience

Line Lead - Second Shift

The Clean Room Line Lead is responsible for leading and directing the CR team in assembly, testing and packaging of medical devices and components. Role is required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

As a team lead, you will be the main contact point for all team members. You will possess the ability to be a team player, team leader and are expected to timely escalate issues to management for resolution. You should lead by setting a good example and engage and motivate the team to achieve daily goals. You will oversee production processes in accordance with OriGen’s policies and procedures.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Daily CR Shift Setup:
    • Equipment inspection and start-up
    • Daily log review/completion
    • Priority assessment and assignment
    • Shift pass down – verify all paperwork is filled out before passing on
  • Report problems or concerns with quality, processes, equipment, materials and staffing to Operations Manager or designee.
  • Meet production schedules and deadlines while maintaining quality standards
  • Work in a flexible and changing environment
  • Communicate, delegate and motivate in a positive manner
  • Lead and motivate team members to meet production goals
  • Follow detailed written and verbal instructions
  • Aid in training members on assembly processes and answers related questions from team
  • Effectively communicate daily concerns and issues with others and management during shift and at shift change
  • Learn multiple tasks and train in other areas as needed
  • Work with a variety of tools and equipment
  • Maintain all logs, paperwork and forms accurately
  • Understand, access and make entries to documents on the company Electronic Document System
  • Accurately perform job duties with minimum supervision
  • Adhere to cleanroom dress code and policies
  • Work in a multi-cultural team environment and be a team player
  • Work in a cleanroom environment for extended periods of time
  • Must be punctual, reliable and willing to lead by example

Required Skill Sets

  • Detailed oriented and able to focus on repetitive tasks for long periods of time
  • Proficient on computer; possessing basic navigation and program knowledge
  • Able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork/Team Leadership

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Close attention to detail
  • Ability to work independently and within a team environment
  • Prior Clean Room experience

Preferred Qualifications

  • Prior experience in a lead position is preferred

Supervisory Responsibility

This position has no direct supervisory responsibilities although the role will be responsible for daily work/task assignment and oversight.

Work Environment

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”. Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
  • Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
  • Note: OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility. There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Compensation

Based on experience and ability

Payroll Clerk

Position Summary

The Payroll Clerk is responsible for managing Finance and HR functions including but not limited to employee records, programs, administration, and compliance for all personnel in support of our culture and environment.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Maintains payroll information by collecting, calculating, and entering data.
  • Updates payroll records by entering changes in exemptions, insurance coverage, savings deductions, and job title and department/division transfers.
  • Prepares reports by compiling summaries of earnings, taxes, deductions, leave, disability, and nontaxable wages.
  • Determines payroll liabilities by calculating employee federal and state income and social security taxes and employer’s social security, unemployment, and workers compensation payments.
  • Resolves payroll discrepancies by collecting and analyzing information.
  • Provides payroll information by answering questions and requests.
  • Maintains payroll operations by following policies and procedures; reporting needed changes.
  • Maintains employee confidence and protects payroll operations by keeping information confidential.
  • Contributes to team effort by accomplishing related results as needed.
  • Employment Verifications
  • Paycor data entry for new hires
  • Follows-up with end of month Benefit changes
  • Vista Print Business Ordering Control
  • Epicor Delegator

Competencies

  • Knowledge of multi-state payroll.
  • Knowledge of wage withholding orders and garnishments.
  • Working knowledge of Excel.
  • Excellent client service skills.
  • Excellent communication skills.
  • Ability to work in a team oriented environment.
  • Ability to work independently in a time sensitive environment.
  • Must possess sound decision making skills and multi-task while working in an environment of stress with specific deadlines.

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Administrative technology certificate or an associate’s degree is preferred
  • Additional certification issued by the American Payroll Association is desired
  • Proven experience working as a payroll clerk in a fast-paced organization
  • Highly proficient in computer skills and technology
  • Accurate and meticulous in data entry
  • Strong clerical, administrative and general office skills
  • Exceptional calculation and memory skills
  • Good organizational and time-management skills
  • Able to sit in front of a computer for long hours at a time

Preferred Qualifications

  • 2-3 years of related experience in Payroll

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.  The facility operates a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience.

Product Marketing Manager

Position Summary

The Product Marketing Manager is responsible for the voice of the customer and works in collaboration with Engineering, Production, Sales and Customer Service to ensure successful product development, production, and marketing throughout the entire product lifecycle. The position will include collaborative development of the market strategy, product positioning, and market research. In addition, this position will conduct research in regards to pricing and further defining customer requirements.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Gathers and analyzes information to identify new markets and customers, demand for products and services, and efficacy of existing marketing campaigns and strategies.
  • Develops and monitors multi-channel marketing plans that support global business objectives.
  • Conducts market research to identify customer requirements for new and current products.
  • Maintains knowledge of trends and developments in the market; identifies needs for new products and makes recommendations to leaderships.
  • Conducts pricing research and analysis to ensure competitive product and service pricing.
  • Develops buyer personas and trains sales on these personas.
  • Composes, develops, evaluates and conducts training on marketing activities, strategies, and policies.
  • Collaborates in the development of Marketing Literature with the Inbound Marketing Specialist, Regulatory, Engineering, Sales and Marketing leadership.
  • Collaborates and participates in promotional activities or trade shows as needed.
  • Negotiates contracts for services needed to execute a marketing strategy.
  • Ensure compliance to all standards regarding marketing materials by working closely with cross-functional colleagues.
  • Develop and implement continuous improvement strategies with the marketing team.

Competencies

  • Creative Problem Solving
  • Collaborative Working
  • Strategic Thinking
  • Research Skills
  • Analytical Skills
  • Results-driven
  • Technologically Savvy
  • Innovative
  • Persuasive

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree
  • Minimum of 3-5 years’ marketing experience
  • Minimum of 1-year experience in medical device or pharmaceutical marketing experience (or another heavily regulated industry)
  • Minimum of 1-2 years’ experience in Market Research
  • Minimum of 1-2 years’ experience in product management, marketing management, or product marketing management
  • Minimum of 1-2 years’ experience in marketing data analysis
  • Minimum of 1-year Google G Suite and Microsoft Office Experience
  • Minimum of 1 years’ experience with an online CRM/Salesforce.com
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
  • Strong ability to understand and interpret customer needs; customer-centric; ability to proactively work with diverse work teams (i.e. Sales, Operations, Human Resources, Quality)
  • Strong interpersonal and people skills
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Strong and effective communication skills (verbal and written)
  • Pays very close attention to detail
  • Ability to work independently and within a team environment on assigned projects from inception to completion
  • Knowledge of FDA, ISO, and MDSAP regulations as it pertains to product marketing

Preferred Qualifications

  • Bachelor’s degree in a related field of marketing, communication, business, or life science related field
  • Minimum of 3 years’ experience in medical device or pharmaceutical marketing

Travel

<10%

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Salary

Commensurate with Experience

Regulatory / Clinical Specialist

Position Summary

The Regulatory/ Clinical Specialist is a key cross-over role between regulatory affairs, regulatory compliance, and clinical affairs. This professional develops and delivers strategy and documentation to support regulatory and clinical objectives within the organization in order to obtain and maintain regulatory approvals and compliance with domestic and international medical device requirements. This staff member is the primary person responsible for delivering clinical strategy, organizing necessary clinical studies or registries, and writing clinical documentation to support access into global markets and support claims desired by OriGen.

Essential Functions

CLINICAL:

  • Developing clinical strategy for on-market or new products, based on new or changing global requirements (such as European Medical Device Regulations 2017/45)
  • Preparing documentation to support clinical deliverables of Technical Documentation, including but not limited to the Clinical Evaluation Report and Post-Market Clinical Follow-Up plans and reports.
  • Managing the planning, organization, execution and results analysis and reporting for any necessary clinical trials or registries, potentially including identifying and collaborating with outsourced CROs.
  • Managing and executing usability studies per ISO 62366
  • Participating in pre-submission meetings with FDA, if needed, to discuss clinical data requirements for new products in the US and presenting justifications for criteria, endpoints, size, and type of clinical trial (i.e. for an IDE or other pre-approval study)
  • Performing literature searches, appraisals, and data analysis for CER and PMS/PSUR
  • Working with marketing and account managers to collect and maintain OriGen literature library
  • Along with account managers, acting as clinical subject matter expert in regards to user risks/ UFMEA and providing input as to clinical hazards and harms
  • Reviewing marketing claims to ensure that they are in alignment with clinical and/or usability validations and data
  • Ensuring any executed clinical studies are in compliance with applicable laws, regulations and guidelines, including GCPs and ISO 14155

REGULATORY:

  • Preparing regulatory submissions for product approval, responding to requests from reviewers, and resolving deficiencies in submissions
  • Creating and maintaining Technical Documentation (as per EU Regulation 2017/745)
  • Preparing documentation to support international registration dossiers and maintain product registration files and electronic registration listing databases
  • Assisting in monitoring and evaluating standards and regulations for changes in regulatory requirements that are applicable to OriGen and OriGen’s products
  • Acting as regulatory representative or independent reviewer on product development teams, providing input to the engineering/project manager
  • Acting as a regulatory/clinical subject matter expert (SME) in on-site audits/inspections
  • Supporting and executing medical device and vigilance reporting, field actions, and recall management
  • Perform regulatory assessment on product or process changes and execute necessary actions such as new 510ks, letters to file, technical file updates, license amendments, etc.
  • Reviewing marketing literature and labeling to ensure claims are in line with indications and validations, as well as verifying that global content requirements are met
  • Executing post-market surveillance (PMS) activities, including PMS Plans, PMS Reports, and PSUR (periodic safety update reports)

Competencies

  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives
  • Interpersonal skills necessary for working effectively in a team environment
  • Works cross functionally to complete projects and testing
  • Exercises judgment and makes sound decisions within broadly defined practices and policies
  • High emotional intelligence and ability to navigate conflict and complex issues
  • Problem-solver at all organizational levels – focused on what is best for OriGen
  • Outstanding communication skills, both written and oral, in communicating across and outside of the organization
  • Ability to actively listen, evaluate alternatives and articulate options, thoughts and ideas
  • High personal and professional integrity and emotional maturity
  • Able to accept positive and constructive feedback with grace, interest and poise
  • Strong ability to influence and persuade

Skillsets & Qualifications

  • Superb technical and clinical writing skills
  • Strong background in statistics and data analysis
  • Experience preparing regulatory submissions/ documentation for at least the US and EU
  • General knowledge of 21 CFR 820 and ISO 13485:2016 requirements
  • Thorough knowledge of GCPs and ISO 14155
  • Thorough knowledge of FDA regulations and guidelines
  • Thorough knowledge of MDR (EU Regulation 2017/745) requirements, particularly in regards to clinical requirements
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.

Required Education and Experience

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 4 years’ experience in medical device regulatory and/or clinical affairs, including as a CRA (may be composed of any combination of regulatory and clinical roles and responsibilities)
  • Demonstrated knowledge and application of domestic and international medical device regulatory and clinical regulations, standards, and best practices

Preferred Education and Experience

  • Certified CRA/CRC or other clinical research certification desired
  • RAC certification is a plus

Supervisory Responsibility

No direct supervisory responsibility is expected for this role, although project management responsibilities may necessitate leadership skills

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Position Type and Expected Hours of Work

This is a full-time position.  Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.

Travel

5-10%

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience.

Supplier Quality Engineer

Position Summary

The Supplier Quality Engineering is responsible for all aspects of supplier quality control for OriGen Biomedical, including qualification, evaluation, monitoring, and re-evaluation of OriGen vendors. This position shares responsibility with the quality department in ensuring that all activities undertaken by the organization are in accordance with quality regulations and standards such as 21 CFR 820, ISO 13485:2016 and MDSAP.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Oversee the supplier quality program, including qualification, classification, and ongoing review of suppliers under a risk-based approach to ensure that supplied materials and services meet internal quality requirements.
  • Assisting purchasing and supply chain with selection of potential suppliers, with particular attention to the ability of the supplier to meet OriGen quality requirements for the service or product to be supplied
    Assessing and evaluating suppliers, with input/approval from quality management, in accordance with company procedures, based on risk of supplied service or product to the safety and performance of OriGen’s final product
  • Performing initial supplier qualification audits, as necessary
  • Classifying suppliers into appropriate risk-based categories and applying necessary controls to ensure that the quality of the product or service provided continuously meets the required specifications
  • Maintain the Approved Supplier List, ensuring all suppliers are listed in the appropriate category
  • Manage and performs supplier evaluation and monitoring, including development and execution of supplier scorecards and criteria for defining the level of control necessary over the supplier based on performance and risk
  • Hold supplier re-evaluation meetings with internal stakeholders/ management to ensure the appropriate level of control is maintained based on risk and performance
  • Direct the Supplier Corrective Action Request (SCAR) program, including issuance of SCARs under specified criteria and follow-up with necessary actions
  • Perform ongoing supplier audits in accordance with supplier performance and risk
  • Maintain professional relationship with suppliers, ensuring effective communication
  • Act as point of contact for suppliers to send requests or notices of changes in supplied product or service
  • Assist engineering with implementation of process and/or control changes taking place at a subcontract manufacturer
  • Lead ongoing supplier monitoring meetings with other internal stakeholders to ensure continued oversight and communication regarding supplier performance and to initiate any necessary actions
  • Develop, maintain, and trend on metrics (i.e. per supplier scorecard or otherwise) for supplier performance and communicate/ present metrics to management as necessary
  • Reports progress, issues, challenges, and opportunities to the Quality Engineering Manager, gathering input, feedback and support as needed to achieve quality goals

Supervisory Responsibility 

No supervisory responsibility at this time

Competencies

  • Demonstrated interpersonal skills, including ability to work cross-functionally to achieve business goals
  • Effective communication skills (verbal and written)
  • Sound critical thinking and independent decision making
  • Adaptability/ flexibility
  • Strong organization and time management skills
  • Proactive and self-starter

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in engineering, science or equivalent
  • 5 years professional work experience in a technical quality assurance position (i.e. quality engineer)
  • Certified lead auditor
  • Quality Systems knowledge in a regulated environment, including subject matter expert knowledge in 21 CFR 820 and ISO 13485:2016

Preferred Qualifications

  • Quality certification (ASQ, etc.)
  • Specific supplier quality experience
  • Experience working in a manufacturing environment with ISO-qualified cleanrooms

Physical Demands and Work Environment 

The physical demands described here are representative of those that must be met by any employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience.

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 5:45am – 2:15pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for: assembly, testing and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Ability to meet production schedules and deadlines according to quality standards
  • Ability to work in a flexible and changing environment
  • Ability to follow detailed written and verbal instructions
  • Ability to learn multiple tasks and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Ability to maintain all logs, paperwork and forms accurately
  • Required to understand, access and make entries to documents on the company Electronic Document System
  • Ability to accurately perform job duties with minimum supervision
  • Ability to adhere to cleanroom dress code and policies
  • Ability to work in a multi-cultural team environment and be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Punctual and Reliable!!

Required Skill Sets

  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be proficient on computer, possessing basic navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment  

Preferred Qualifications

  • Prior Clean Room experience preferred

Compensation

Based on experience and ability