Senior Quality Engineer

Role Highlights

• Ensure compliance with FDA, ISO 13485, EU MDR
• Lead CAPA investigations, non-conformance resolution, and process validation (IQ/OQ/PQ)
• Collaborate with R&D and manufacturing to integrate quality into product design
• Support audits, supplier quality, and regulatory submissions (FDA 510(k), CE Mark)
• Drive continuous improvement using tools like FMEA and SPC

• Bachelor's in Engineering or related field
• 6+ years in medical device quality engineering
• Strong knowledge of FDA QSR, ISO 13485, EU MDR
• Experience with process validation and quality tools

Salary: $115K-$150K + comprehensive benefits
Interested? Reply with your resume or reach out for details!

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.