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New Job Opportunity: QA Consultant / QMS Implementation (Part Time)


Support the implementation of a new QMS per the requirements of FDA 21 CFR Part 820 and ISO 13485:2016. Activities include, but are not limited to:

  • Set up procedure requirements, to ensure they can be exercised, for the implementation of all QMS processes, including training, production controls, equipment control, non-conformance, CAPAs, audits, acceptance activities, etc.

  • Drive activities to set up an electronic QMS.

  • Author procedures, such as process work instructions, incoming inspection procedures, etc.

  • Engage team in weekly activities, to ensure implementation of a new QMS.

  • Ability to work with different small teams and take directions from Sr. Consultant.

  • Ability to work approximately 15-25 hours per week for about 4-6 months (some remote work is allowed).

Education, Experience and Background Requirements

  • 5+ years of experience in a quality role at a medical device company.

  • Background/education in engineering/science or related field.

Training and Skills Requirements

  • Strong communication skills and experience working in small teams.

  • Experience with FDA 21 CFR Part 820, ISO 13485:2016.


  • Send us a copy of your resume to with the subject “QA Consultant / QMS Implementation (Part Time)”

  • Write a brief description of why you think you are a good fit for this role.

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