Quality Engineer – Medical Device (CAPA, ISO 13485, Risk Management)

About Company

Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.

Job Summary

Our client, a medical device manufacturer, is seeking a Quality Engineer to support quality systems and product quality activities in an FDA-regulated environment. The role covers CAPA and non-conformance investigations, risk management, design control support and process validation, working cross-functionally with Manufacturing, Engineering and Regulatory teams.

Responsibilities

• Lead and support CAPA and non-conformance investigations through root cause analysis to closure
• Develop and maintain risk management files per ISO 14971, including DFMEA and PFMEA
• Support design control activities and Design History File (DHF) documentation
• Review and approve process validation protocols and reports (IQ/OQ/PQ)
• Perform inspection method and test method validation
• Apply statistical techniques for sampling plans, capability studies and Gage R&R
• Support supplier quality activities and internal audits
• Support FDA and notified body inspection readiness

Qualifications

• Bachelor's degree in Engineering or a related technical discipline
• 3–5 years of quality engineering experience in medical device manufacturing
• Working knowledge of ISO 13485, ISO 14971 and 21 CFR Part 820 (QSR)
• Experience with CAPA, non-conformances and complaint investigations
• Risk management experience including DFMEA and PFMEA
• Statistical methods and sampling plans, Minitab preferred
• Must be legally authorized to work in the United States
• W2 employment only

Please send your resume to deepika.b@starkpharma.com. In your email, please include your current location, your hourly rate expectation on W2, and your availability to start.