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.
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