Responsibilities
Actively execute quality assurance in design development, including but not limited to:
Support design control deliverables.
Author verification and validation protocols and reports.
Author test method validation such Gauge R&R and Attribute Agreement Analysis.
Drive execution of verification and validation activities.
Support writing and approving risk management documentation, such as risk management plans, risk analysis, FMEAs, risk management review/ report, etc.
Engage team in weekly activities, to ensure design control activities are being carried out in accordance with the company procedures and applicable regulatory requirements.
Ability to work with different small teams and take directions from Sr. Consultant.
Ability to work approximately 30-40 hours per week (remote work is allowed).
Main project duration is 3-6 months. Additional projects may be available upon completion of main project.
Education, Experience and Background Requirements
7+ years of experience in a product development 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.
Apply
Send us a copy of your resume to admin@qesmedical.com with the subject “QA Consultant / Design Control”
Write a brief description of why you think you are a good fit for this role.
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