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.

OriGen Biomedical manufactures essential, life-saving products.  As such, OriGen is an essential business and some jobs may be required to work onsite. Your health and safety is important, and while we take pride in our everyday practices to maintain a clean and sanitary environment within our facilities, at present, we have implemented additional measures that reflect the recommended standards of the Centers for Disease Control and Prevention (CDC) in response to the coronavirus.

Current Job Openings:

Director, QA/RA

Director of Quality Assurance and Regulatory Affairs in Austin, TX

Located in Austin Texas, we are a well-established, fast-growing, medium size medical device company specializing in devices for cryopreservation and cell culture. We are currently looking for an experienced Quality Assurance and Regulatory Affairs (QA/RA) Director to join our team.

Position Summary

The QA/RA Director is responsible ensuring compliance with global medical device regulations including CFR, ISO 13485 and MDSAP requirements. This position will manage both the Regulatory and Quality staff.

Essential Duties and Responsibilities

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

  • Develops a forward-looking compliance program to maintain global distribution of medical devices.
  • Advocate for and work within a medium size device firm.
  • Ensures that the Quality System requirements are established and maintained as described in applicable FDA and International Standards.
  • Provide clear and concise reporting on QA and RA functions.
  • Technical writing, direction and submission of Regulatory documentation.
  • Manage and improve the Quality function through direct report supervisors.
  • Oversees Quality Assurance functions, including
    • All internal and external audits
    • CAPA, complaints and MRBs
    • Supplier assessment
    • Training programs
    • Design control
  • Maintains and updates Technical Files on company’s devices.
  • Works with other departments to integrate Regulatory and Quality requirements into all processes.
  • Assists our Distributors in meeting local regulatory requirements.
  • Leads their team to achieve deadlines on time and on budget.
  • Participates in all phases of Product Design.
  • Participates in Strategic Planning.

Competencies

  • Proven Leadership Skills
  • Intimate knowledge of Regulatory environment for medical devices, CFR, 13485. MDR
  • Cost conscious, small company attitude
  • Excellent communication and interpersonal skills
  • Superior organizational and time management skills
  • Sound decision making
  • Ethical Conduct
  • Close attention to detail
  • Broad creativity and curiosity
  • Effective problem-solving skills
  • Adaptability, can work with changing priorities

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Science/Math/Engineering
  • 10+ years’ experience in QA / RA in medical device manufacturing
  • 5+ years of leadership experience
  • 4+ years’ recent experience in CFR / ISO 13485 environment
  • Audit experience with FDA and Notified Bodies
  • Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
  • Ability to work independently and lead in a team environment

Preferred Qualifications

  • Masters’ degree in a related discipline
  • Professional certification preferred (ASQ CQA, CQE, C Q. Mgr, CQA-Biomedical, RAC)

Supervisory Responsibility

This position supervises of a department of thirteen.  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.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Key Account Manager

Position Summary

Key Account Management (KAM) is a strategic program that encompasses the entire organization—not just sales. This individual will be the lead point of contact for all key account matters, anticipates the accounts’ needs, works within the company to ensure deadlines for these accounts are met, and helps the accounts succeed. Sustains and nurtures solid relationships with specified key customers. Identifies key customer needs and is passionate about exceeding customer expectations. Utilizes company resources to develop and implement strategic solutions to achieve key clients’ long-term goals while also meeting or exceeding OriGen Biomedical’s business goals.

Essential Duties and Responsibilities

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

  • Resolve key customer issues
  • Develop a trusted advisor relationship with key accounts, customer stakeholders and executive sponsors
  • Collaborating with internal departments to ensure all customer needs are met
  • Developing a complete understanding of key account needs
  • Anticipating key account challenges, changes and improvements
  • Managing communications between key clients and internal teams
  • With internal stakeholders, facilitates negotiation of contracts and agreements with the client
  • Forecast, track, document and report on key account metrics
  • Collaborating with the sales team to maximize profit by up-selling or cross-selling
  • Planning and presenting reports on account progress, goals, and quarterly initiatives to share with team members, stakeholders, and possible use in future case studies or company training
  • Meeting all client needs and deliverables according to proposed timelines
  • Developing a deep understanding of OriGen’s products, processes, documents, and other resources necessary to perform duties
  • Provide technical support to sales and account managers on issues not resolved with available resources
  • Coordinates and follows up with all customer requests for technical information
  • Maintains their technical understanding of our products. Obtains ongoing certification or education for their industry/client base
  • Actively seeks new opportunities for OriGen’s products and services
  • Participates in sales meetings and training of new technical personnel
  • Assists in budgeting and planning as required
  • Provide sales call activity and reporting for all sales meetings
  • Follows all OriGen SOP’s
  • Maintains a friendly and professional demeanor with all customers, partners, and teammates
  • Maintains an electronic calendar of all scheduled commitments for management to view
  • Responsible for timely expense reporting according to OriGen policy

Competencies

Communication

As the liaison for the customer and the rest of the company, the KAM has to excel at communicating in person, over the phone, via email, and across teams. Must be comfortable addressing each level of the business to ensure the customer’s needs and expectations are properly met, including C-suite executives.

Company and customer expertise

The KAM must (develop) possess an in-depth knowledge of OriGen and its customers in order to nurture strategic relationships with top customers. This facilitates identifying the best opportunities for growth and service to the customer. This is particularly important given the unique needs and expectations of key customers. Curated custom solutions may need to be tailored to the customer’s specific needs. An understanding of each part of the business (account’s strategy, market position, budget, and goals) is necessary to be able to communicate effectively to build bespoke offers.

Strategic perspective

Must have a strategic perspective that goes beyond short-term gains. Able to juggle many moving parts and orchestrate deals and long-term plans that align with a mutually beneficial strategy.

Leadership

Must have leadership qualities and adept at directing customers and managing employees at all levels of the business. A visionary expected to lead both customers and internal stakeholders on key initiatives.

Skilled negotiation

Able to build lifetime value of key customers by not only selling but also by brokering mutually beneficial terms. This requires a keen sense of timing, excellent presentation skills, and the confidence to hold your ground and know when to push back.

Value-based selling

Able to effectively communicate the value of OriGen’s offerings to key customers, both strategically and financially.

  • Cell Therapy/Biotech industry knowledge
  • Teamwork
  • Planning
  • Build Relationships
  • People Skills
  • Initiative
  • Customer Focus
  • Emphasize Excellence
  • Attention to Detail
  • Deep digital understanding
  • Excellent listening, negotiation and presentation abilities
  • Experience delivering client-focused solutions to customer needs
  • Proven ability to juggle multiple account management projects at a time, while maintaining sharp attention to detail
  • Financial Management
  • Strategic Thought
  • Innovation
  • Adaptability
  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Decision making
  • Interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • A Bachelor degree in Sales, Marketing, Business, or related field
  • 3-5 years of previous work experience in sales, management, account management, and relevant experience in Cell Therapy, Biotechnology, or related field
  • Proven results of delivering client solutions and meeting sales goals
  • Able to multitask, prioritize, focus on details, and manage time efficiently
  • Goal-oriented, organized team player
  • Encouraging to team and staff; able to mentor and lead
  • Self-motivated and self-directed
  • Excellent interpersonal relationship skills
  • In-depth understanding of company key clients and their position in the industry
  • Eager to expand the company with new sales, clients, and territories
  • Able to analyze data and sales statistics and translate results into better solutions
  • Excellent verbal and written communication skills; must be a listener, a presenter, and a people-person
  • Excellent computer skills, and experience with CRM software and office productivity software
  • Strong negotiation skills, with ability to follow-through on client contracts
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshooting ability
  • Strong ability to understand and interpret customer needs; customer-centric; ability to proactively work with diverse work teams (i.e. Sales, Operations, Marketing, Quality, Regulatory, Engineering)
  • Ability to work independently and within a team environment on assigned projects from inception to completion
  • Knowledge of FDA regulations and guidelines for medical device process validation
  • Proficiency in technical and layman writing

Preferred Qualifications

  • Master’s degree in Business Administration, Finance, Sales, or related field
  • 1-3 years of previous work experience in sales, management, key account management, or relevant experience
  • 1-2 years of account management experience in Cell Therapy, Biotech, or related field
  • Experience in key account management
  • Proficiency with Microsoft Office, G-Suite, Asana, and Salesforce software
  • Experience with building rapport with key clients
  • Experience in handling multiple key customer accounts
  • 1-2 years of strong negotiation and leadership skills
  • 1-2 years of customer service experience

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 (and/or remote home-based). 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 work environment is usually moderate.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Logistics Specialist

The Logistics Specialist works with limited supervision and is responsible for domestic and international shipping for the company. He/she also informs customers of outgoing shipments by providing accurate tracking information and keeps the finished goods warehouse and shipping office clean and organized.

Essential Functions

Primary Duties

  • Manages domestic and international shipments of finished medical devices.
  • Pulls and packs shipments, prepares paperwork and all required shipping documents to accompany shipments.
  • Responsible for maintaining the warehouse and shipping areas, including restocking, counting, organizing and cleaning.
  • Prepare custom orders for customers, relabeling, packing, shrink wrap, etc.
  • Maintains and organizes files, and additional duties as assigned.
  • Will perform inventory management functions, moving inventory and maintaining appropriate counts.
  • Will perform shipping and receiving functions, including crating and packaging operations.
  • Will assist in moving released products into the Finished Goods warehouse.

Secondary Duties

  • Corresponds with customers and distributors by email, fax and telephone.
  • Responsible for organizing and delivering documents as needed by International Distributors for regulatory clearance in their countries.
  • May occasionally manage inward customs clearance for shipments from overseas.
  • Will perform some customer service functions and routine office duties including filing, records checking, answering telephone, taking of orders, written communications, and other light clerical work, as needed.

Competencies

  • Self-starter capable of setting and communicating priorities and managing day to day tasks.
  • Collaborative skills to work cross functionally to accomplish deadlines and objectives.
  • Interpersonal skills and ability to work in a team environment.
  • Ability to exercise judgment and make sound decisions within broadly defined practices and policies.
  • Outstanding written and oral communication skills and ability to communicate at all levels of organization.
  • Strong customer focus/orientation
  • Good time management and listening skills

Skillsets/Qualifications

  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel
  • Prior logistics/shipping/inventory control experience

Required Education and Experience

  • High school degree or equivalent

Preferred Education and Experience

  • College Degree or equivalent

Supervisory Responsibility

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

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

None

Work Environment

This job operates in a climate-controlled warehouse/distribution area and a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

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 see, talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is regularly required to stand; walk; sit; and reach with hands and arms. The employee must regularly lift and/or move up to 60 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 but there may be increased noise or fumes in the warehouse and/or shipping and receiving areas.

Logistics Supervisor

Position Summary

The Logistics Supervisor oversees the shipping and delivery of materials and warehouse personnel. This individual will mainly work in the warehouse settings and are involved in managing the loading of trucks, setting up delivery routes and unloading of material. Ensuring that the inventory system is fully operational, meaning products are moving into and out of finished goods to customers in a timely manner, the products are stored in line with their requirements, and our freight providers are in good standing. This individual will direct, optimize and coordinate customer order cycle.

Essential Functions

Shipping and Receiving:

Primary Duties

  • Manage, coach and train the team with picking, packing, software, and equipment training.
  • Lead the team to streamline customer shipment process. Increasing the current turnaround time and output to customers.
  • Plan, implement and maintain the finished goods warehouse for optimal product flow.
  • Manages global shipments of finished medical devices for over 200 SKUs.
  • Reviews daily shipment and open order report and communicates daily update to customer service, sales and logistic teams.
  • Maintain knowledge of international codes and information necessary for international shipment clearances, importing and exporting from the USA.
  • Communicated, implemented, and monitored safety programs and procedures to ensure proper use and maintenance of equipment.
  • Maintain metrics and analyze data to assess performance and implement improvements to meet cost, productivity, accuracy and timeliness targets. (ex, lean inventory, on time delivery)
  • Will oversee inventory management functions, moving inventory and maintaining appropriate counts.
  • Leader for ISO internal auditing, training, and procedure writing for logistic operations.
  • Coordinate with QA to ensure all expiring products are removed from Finished Goods.
  • Review, maintain and create SOPs as necessary.
  • Responsible for overseeing the maintenance of the finished goods warehouse and shipping office and associated areas, including restocking, counting, organizing and cleaning.
  • Weekly reporting on department metrics to your manager. These will be updated and created collaboratively.

Secondary Duties

  • Responsible for organizing and delivering documents as needed by International Distributors for regulatory clearance in their countries.
  • May occasionally manage inward customs clearance for shipments from overseas.
  • Maintains and organizes files, and additional duties as assigned.
  • Negotiate carrier contracts, and outside sourcing.
  • Comply with laws, regulations and OHS&E requirements.

Competencies

  • Self-starter capable of setting and communicating priorities and managing day to day tasks.
  • Interpersonal skills and ability to work in a team environment.
  • Ability to exercise judgment and make sound decisions within broadly defined practices and policies.
  • Outstanding written and oral communication skills and ability to communicate at all levels of organization.
  • Strong customer focus/orientation.
  • Ability to work independently and lead in a team environment

Skillsets/Qualifications

  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • At least 3 years of proven working experience as a logistics specialist.
  • Having strong communication skills to manage the internal and external stakeholder expectations to provide timely information.
  • Strong leadership talent, interpersonal and organizational skills.

Required Education and Experience

  • Associates Degree
  • 3 years of manufacturing & warehouse experience
  • 2 years management experience

Preferred Education and Experience

  • Bachelor’s Degree
  • 3 years of manufacturing & warehouse experience in biomedical industry
  • 5 years management experience

Supervisory Responsibility

This position has direct supervision of a department of 3. The individual will also be required to lead project teams and ensure participants meet deadlines.

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:00 a.m. to 4:30 p.m. In some cases, additional work hours may be required.

Travel

May have travel between other OriGen facilities.

Work Environment

This job operates in a climate-controlled warehouse/distribution area and a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

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 see, 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 60 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 but there may be increased noise or fumes in the warehouse and/or shipping and receiving areas.

Compensation

Based on experience and ability

Process Engineer Manager

Position Summary

The Process Engineer Manager will lead a team of process and manufacturing engineers and tool technicians to develop and validate new and existing manufacturing processes to ensure quality, cost, and efficiency requirements are met in the production of medical devices; troubleshoot problems with production and take corrective action; research the purchase of new equipment and updates to existing equipment; manage the preventative maintenance of existing equipment; provide individual goals and career development to the process and manufacturing engineering group.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Engineering activities include:

  • Draft and oversee execution of protocols to validate manufacturing processes.
  • Maintain the site Validation Master Plan for multiple manufacturing sites.
  • Work with product development to plan, implement, and validate processes for new product development and product variants.
  • Research, propose, purchase, and perform IQ/OQ/PQ on new equipment. Serve as project manager for large-scale equipment purchases.
  • Establish monitoring program for essential processes to maintain validation, mitigate risk, and improve efficiency.
  • Evaluate and document process risks that tie into validation.
  • Execute the preventative maintenance program for existing equipment
  • Participate in regulatory, customer, and internal audits that pertain to process validation and equipment qualification.
  • Write new and revise existing Standard Operating Procedures and manufacturing instructions based on outcomes of process validation.
  • Effectively train operators, technicians, and engineers on use of equipment and fixtures.
  • Review design of production tooling and fixturing as required.
  • Provide input to new product development teams for design for manufacturability.
  • Investigate and report on customer complaints related to process issues.
  • Identify existing bottlenecks in production and suggest improvements to improve workflow and efficiency.
  • Support production through effective identification and resolution of line issues.
  • Perform Root Cause Analysis of process related problems, plan, and implement corrective actions.

Supervisory Responsibility

  • Process engineering team consists of process and manufacturing engineers and engineering technicians.
  • For each team member:
    • Establish performance indicators and individual goals member that align with company objectives.
    • Assess the performance and provide summarized review annually.
    • Provide career development plans.
    • Hold weekly one-on-ones.
    • Provide input to annual engineering budget plan.
    • Complete job requisition requests for new positions as needed to support company growth.

Skill set

  • Knowledge of FDA regulations and GMP guidelines for medical device process validation.
  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Proficiency in technical and layman writing.
  • Works in cross functional teams to complete projects and testing.
  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, and will be expected to communicate directly with production management, production technicians, engineers, and senior management.

Competencies

  • Self-motivated
  • Broad creativity and curiosity
  • Problem-solving skills
  • Project Management
  • Ethical Conduct
  • Communication and interpersonal skills
  • Strategic Thought
  • Adaptability
  • DOE and Validation testing
  • Decision making
  • Corrective and preventative actions

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Engineering
  • 4+ years’ experience in medical devices / ISO 13485 environment
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
  • 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)
  • Close attention to detail
  • Ability to work independently and lead or participate in a cross-functional team environment

Preferred Qualifications

  • ISO 13485 experience

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.

QA Technician, Inspector - 2nd Shift

The QA Technician, Inspector works with limited supervision to conduct incoming, in-process, and final product inspection; support the control and disposition of nonconforming materials and supplier corrective actions; calibrate equipment; create, finalize and maintain quality records; process customer returns; and print product labels.

Essential Duties and Responsibilities

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

  • Performs inspections of incoming, in-process, and final product for conformance to quality assurance standards using an approved sampling plan.
  • Accurately completes all quality control documentation and inspection sheets in accordance with ISO 13485 Standard and established procedures.
  • Verify inspection equipment, machinery and tools used are calibrated per company policy.
  • Follows verbal and/or written instructions such as production traveler, work instruction, process specifications, and drawings at the direction of supervisor in completing a variety of inspection tasks.
  • Makes decisions as to the acceptable quality; determines reasons for rejection; completes required quality records.
  • Identify, initiate quarantine, report and document all nonconforming product.
  • Bring problems/issues to attention of Management.
  • Work efficiently to achieve targeted goals as set by the production schedule.
  • Participates and/or assists with cross training activities, training of new hires and temporary staff.
  • Follows set training program for position and ensures training requirements are up to date.
  • Demonstrates safe work habits, maintain clean and safe work area.
  • Performs other duties as assigned, to maintain efficiency throughout the company.
  • Conducts equipment calibration activities, requiring a good understanding of current metrology practices and use of measuring instruments.

Competencies

  • Self-starter
  • Close attention to detail
  • Ability to perform product inspections, including understanding of drawing dimensions and tolerances.
  • Understanding of the selection and use of sampling plans.
  • Familiar with quality tools and procedures
  • Creativity and curiosity
  • Organizational and time management skills
  • Good math, technical writing and computer skills.
  • Effective problem-solving skills
  • Ethical Conduct
  • Communication and interpersonal skills
  • Adaptability, can work with changing priorities
  • Measured decision making
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • High school diploma
  • 1 – 3+ years’ experience working within a formalized FDA or ISO Quality System.
  • 1 – 3+ years’ experience within a medical device manufacturing environment.

Preferred Qualifications

  • Associate degree or professional certification

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.

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.

  • 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 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.

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