Current Job Openings:

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 6:00am – 2:30pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:00pm – 12:30am). 

Our company is looking for full-time production personnel to work in a clean room environment for:

Overall job description: 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. 

Job requirements:

  • 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 task and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required
  • 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 as well as be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Ability to read, write, speak and understand English
  • 20/20 Corrective Vision Required
  • Punctual and Reliable!!

Compensation
Based on experience and ability
Past experience working in a GMP environment is definitely a plus, but not required 
And other duties as assigned by the team leads or supervisor

For more information or to apply, please email Morning Shift for the morning shift or  Evening Shift for the evening shift.  Resumes can also be sent via fax or mail, or applications filled out at our office.

Customer Service Representative I

The Customer Service Representative I shall be responsible for primary customer contact.  They will be the first point of contact for customer service calls, emails, and fax communications.  They must remain friendly and courteous at all times. Candidate is expected to develop an understanding of the product lines and be able to quickly assist customers with requests, inquiries and orders.  A basic understanding of OriGen Products will be required/expected.

Essential Duties and Responsibilities

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

  • Creating new accounts, checking credit references, setting credit limits and terms
  • Assisting with answering phones when receptionist is unavailable
  • Maintaining a friendly and courteous telephone persona while asking probing/appropriate questions and taking phone orders
  • Accurately transferring all orders sent via fax, email or taken over the phone to our ERP system and following up with the logistics team
  • Coordinating lead times with Production staff and communicating clearly/accurately to the customer
  • Assisting customers with returns and following up with Accounting to ensure that credit notes are sent or refunds issued.  
  • Issuing both verbal and written quotes as needed.
  • Accurately delivering sample requests from a variety of sources.
  • Careful organization of work and timely responses are required.
  • Creating a weekly report of sample shipments and following up on customer satisfaction with samples received outside of USA and Canada.
  • Cross training with logistics on customer shipment duties and performing those duties as needed/ assigned
  • Other duties as assigned

Skill set

  • Proven skills in coordinating and managing day to day tasks, problem solving, and working in a collaborative, team environment to meet deadlines and accomplish goals/objectives.
  • Knowledge and skill in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral –  must communicate effectively with all departments and at all levels.
  • Ability to manage shifting priorities in a pro-active and professional manner.  High emotional intelligence and ability to self-regulate stress response and personal emotions.

 

Competencies

  • Results-driven/Problem Solving
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills
  • Stress Management

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Associates degree
  • One year of customer service experience
  • Strong ability to understand and interpret customer needs
  • 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 – natural problem solver
  • Ability to work independently and within a team environment on assigned projects from inception to completion

Preferred Qualifications

  • Bachelor’s Degree
  • Two years of customer service/related experience in Medical Device Industry
  • Experience with stringent regulatory environment 

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.

Note:  OriGen is a smoke/vape and fragrance-free environment.  NO smoking/vaping of any kind is permitted while on Company property or during work hours.  No scented products beyond deodorant are permitted; e.g. perfume, cologne, after-shave, scented lotions, oils, hair products, etc.   

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

QA Manager

Position Summary

The QA Manager is responsible for running the entire QA operation at OriGen Biomedical

Essential Duties and Responsibilities

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

  • Direct all daily activities of the QA department

  • Manage and train personnel in all Quality functions including

    • Monitoring and improving all processes that affect product quality

    • Product Inspection

    • Non-Conforming materials

    • Vendor qualification

    • CAPA Investigations and monitoring

    • Complaint processing

    • Internal audits and scheduling

    • Process and Site validations

  • Present weekly Quality Report to Management

  • Keep processes and procedures aligned with current standards

  • Manage external audits and close findings

  • Document progress towards current objectives

  • Working in a small company, juggling many roles

Supervisory Responsibility

  • Supervises department (six and growing)

  • Develops and optimizes department schedules

  • Maintains training of current QA staff

  • Recruits and trains new QA personnel

  • Works closely with other Supervisory personnel

Competencies

  • Broad Quality systems knowledge

  • Proven Leadership

  • Demonstrated Interpersonal skills

  • Effective communication skills (verbal and written)

  • Sound Decision making

  • Adaptability/ Flexibility

  • Teachable

  • Team building, motivation

  • Ethical Conduct

  • Strong computer skills

  • Innovation

Minimum Qualifications (Knowledge, Skills, and Abilities)

 

  • Bachelor’s degree in Science, or equivalent

  • 6 years professional work experience Quality Assurance

  • 4 Years departmental leadership experience

  • Sound problem solving and critical thinking skills; strong troubleshoot ability

  • Confident interpersonal skills

  • Strong organization and time management skills

  • Attention to detail

  • Self-starter

  • Teamwork skills as member and leader

Preferred Qualifications

  • Quality Assurance work in Medical Devices

  • ISO 13485 experience

  • Experience in sterile fill operations

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
 

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

QA Specialist I/II

Position Summary

The QA (Quality Assurance) Specialist I/II develops programs to support and implement the Quality Management System as developed for OriGen products and processes.  This includes creation of documents and reports on both product quality as well as the effectiveness of the Quality system. Working with the QA Manager (and/or RA/QA Director), they will create a system of continuous improvement for both products and quality reporting.  

Essential Functions

Quality activities include:

  • Write, revise, and approve documents and reports related to quality system activities.
  • Works to increase outgoing product quality
  • Works with suppliers to maintain and improve incoming material quality
  • Works with QA staff to maintain and increase competency and efficiency
  • Manage the Electronic QMS, and train others in its use
  • Assist with document control activities
  • Assist with risk assessment/ risk analysis
  • Performs corrective/preventive action planning and execution
  • Performs complaint investigation and trending
  • Conducts and supervises Internal Audits
  • Prepares for and participates in inspections/audits by external auditing organizations and customers
  • Assists with field actions including FSCAs and recalls
  • Assists in development of Management Review content

Competencies

  • Thorough knowledge of 21 CFR 820, ISO 13485:2016 and MDSAP requirements
  • Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
  • Familiar with using an eQMS system
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Interpersonal skills necessary to work effectively in a team environment.
  • Works cross functionally to complete projects and testing.
  • Exercises judgment within broadly defined practices and policies.
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization

Required Education and Experience

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 3 years’ experience in medical device quality assurance discipline: knowledge of domestic and international medical device quality system regulations and standards

Preferred Education and Experience

  • Certified Internal Auditor (ASQ or similar program)
  • Experience in ERP and eQMS/eDMS systems

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

5%

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.

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

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

Process Engineer

Summary

Validate existing and develop new manufacturing processes to ensure quality, cost, and efficiency requirements are met in the manufacture of medical devices. Troubleshoot problems with production and take corrective action. Research the purchase of new equipment and updates to existing equipment.

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 existing manufacturing processes.
  • 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.
  • Establish monitoring program for essential processes to maintain validation, mitigate risk, and improve efficiency.
  • Evaluate and document process risks and tie into validation.
  • Write new and revise existing Standard Operating Procedures based on outcomes of process validation.
  • 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.

Competencies

  • Knowledge of FDA regulations and 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 cross functionally 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.

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.

 

Salary:

Commensurate with Experience

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

RA Specialist I/II

Position Summary

The RA (Regulatory Affairs) Specialist I/II develops documentation to support the Regulatory objectives for OriGen products.  This staff member works to maintain continuous compliance with domestic and international regulatory requirements and standards.  Working closely with the RA Director, they develop and submit regulatory filings and submissions for authorization to market products in US, EU,  Canada, and other international markets as necessary.

Essential Functions

Regulatory activities include:

  • Executing regulatory strategy by preparing submissions for product approval, responding to requests from reviewers, and resolving deficiencies in submissions.
  • Prepare documentation to support international registration dossiers and maintain product registration files and electronic databases.
  • Monitoring standards for changes in regulatory requirements.
  • Act as regulatory representative on product development teams, providing regulatory input to the engineering/project manager
  • Helps maintain Design History Files (DHF), design dossiers, and technical files following product approval.
  • Working with outside auditors to demonstrate regulatory compliance
  • Support medical device reporting and recall management
  • Working with business partners to investigate regulatory pathways/ develop regulatory strategy for new products and/or changes to existing products.
  • 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.
  • Assists in development of Management Review content

Competencies

  • Proven skills in preparing regulatory submissions in the US and Europe (510(k), de Novo and Technical Files).  Experience with international regulatory submissions is a plus.
  • Knowledge of FDA regulations and guidelines, including 21 CFR 820.
  • Knowledge of MDR requirements
  • Knowledge of ISO 13485: 2016 and MDSAP.
  • 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 within broadly defined practices and policies.
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization

Required Education and Experience

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 3years’ experience in medical device regulatory affairs discipline: knowledge of domestic and international medical device regulation, practical experience in global registrations and filings (i.e. US, EU, Canada.)

Preferred Education and Experience

  • Completion of RAPS Regulatory Affairs Certification program.
  • RAC certification by examination desired.

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 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%

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

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