Quality Assurance Specialist
4 days ago
Job Overview
Barton Staffing Solutions is seeking a highly experienced Quality Assurance Specialist for their client, a leading contract manufacturer of medical devices. As a key member of the quality team, you will be responsible for ensuring compliance with quality-related engineering needs.
About the Role
- This is a direct hire position that requires a strong background in medical device quality assurance and processes.
- The ideal candidate will have at least 5 years' experience in medical device manufacturing and a deep understanding of quality systems policies and regulations (ISO 13485 and FDA Part 820).
- You will work closely with operations, supply chain, and new product development teams to ensure seamless collaboration and effective problem-solving.
Key Responsibilities
- Lead in supporting compliance for medical device manufacturers in ID/traceability throughout the supply chain.
- Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment.
- Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management are also key responsibilities.
- CORRECTIVE AND PREVENTIVE ACTION MANAGEMENT, FACILITATION, OWNERSHIP, AND PROBLEM RESOLUTION ARE KEY ASPECTS OF THIS ROLE.
- Process improvement and support, including Quality System process review and revision, are also essential duties.
- Training assistance, internal and external audit coordination, and facilitation are other key responsibilities.
What We Offer
- A competitive salary range of $70,000 - $90,000.
- An excellent benefit package, including opportunities for growth and professional development.
Requirements
- A Bachelor's degree in science, engineering, or equivalent.
- At least 10 years of relevant experience in medical device manufacturing.
- 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.
- Familiarity with statistical analysis.
How to Apply
Please apply online at www.Bartonstaffing.com or send your resume to our website for consideration.
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