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:

QA Engineering Manager

Position Summary

The QA Engineering Manager is responsible for all quality system and product quality activities for OriGen Biomedical, including ensuring compliance to global quality system regulations and standards such as 21 CFR 820, ISO 13485:2016 and MDSAP. This position oversees the quality team and manages the daily activities associated with releasing high quality products under a compliant quality management system.

Essential Duties and Responsibilities

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

  • Leads a team of quality personnel, including specialists, and engineers, acting as a mentor and facilitating effective communication and workload/priority management
  • Ensure effectiveness of the quality management system, including planning, managing and executing quality policies, procedures, and programs
  • Ensure compliance of the quality management system with global regulations and standards
  • Provides advice and knowledge in regard to interpreting cGMP/QSR guidelines and regulations
  • Evaluate the performance of the production process and quality of resulting products to improve existing methods of operation
  • Identify and guide areas of QMS improvement and enhancement to meet both the needs of the organization and any new or changing regulatory requirements
  • Coordinate internal and external quality system audits, including those from regulatory authorities, notified bodies, and customers
  • Manage the complaint and CAPA processes, including efficient resolution of complaints and implementation of appropriate corrective and preventive actions to correct or prevent deficiencies
  • Carry out vendor qualification and act as primary contact for customers wanting to qualify OriGen as a vendor
  • Manage document and change control procedures, as well as the training program to ensure all employees maintain training to pertinent procedures
  • Proactively looks for opportunities to identify change, increase efficiency, influence decisions and deliver results while ensuring compliance
  • Develops, modifies, and drives towards meeting quality metrics that successfully measure the output and adequacy of the quality system
  • Reports progress, issues, challenges, and opportunities to the Director of RA/QA, gathering input, feedback and support as needed to achieve quality goals

Supervisory responsibility

  • Supervises department of 3 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

  • Building Relationships: proven leadership, including ability to motivate, teach/mentor and delegate
  • Teamwork – build a team and be a member of the team
  • Demonstrated interpersonal skills, including ability to work cross-functionally to achieve business goals
  • Conflict Resolution
  • Effective communication skills (verbal and written)
  • Performance management
  • Sound critical thinking, problem solving and independent decision making
  • Adaptability/ flexibility – open to others thoughts/ideas
  • Self-awareness – ability to give and receive feedback and regulate emotions
  • Strong organization and time management skills
  • Proactive and self-starter

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Science, or equivalent
  • 6 years professional work experience Quality Assurance
  • 2 years direct supervisory/ leadership experience
  • Quality Systems knowledge in a regulated environment, including subject matter expert knowledge in 21 CFR 820 and ISO 13485:2016

Preferred Qualifications

  • Experience with both quality system and quality engineering/ product quality
  • Experience and sound knowledge in MDSAP requirements and audits
  • 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.

QA Technician, Inspector

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.

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