Medical Device Quality Assurance Manager
3 weeks ago
This role is responsible for ensuring compliance and risk analysis, process validation, and quality-related engineering needs of the organization. As a key member of the operations team, you will work closely with supply chain and new product development teams to ensure seamless collaboration.
The ideal candidate will have strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes. Experience conducting supplier audits and writing supplier contracts is highly desirable.
We are offering a competitive salary of $120,000 - $150,000 per year, depending on experience, plus a comprehensive benefits package. Our company, AJR Enterprises, LLC, is a leading contract manufacturer of superior medical devices and advanced manufacturing solutions within the medical device industry.
Key Responsibilities:
- Lead in supporting compliance for medical device manufacturers in ID/Traceability throughout the supply chain, well-documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, Process Validation.
- Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management.
- Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment.
- Design and execution of pFEMA's, IQ, OQ, PQ, and PPQ validation.
- Corrective and Preventive Action management, facilitation, ownership, and problem resolution.
- Process improvement and support, including Quality System process review and revision.
- Training assistance, including providing training in quality system activities/requirements.
- Internal and external audit coordination and facilitation.
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