Senior Quality Engineer

Senior Medical Device Quality Engineer

Join a growing medical device company that is looking for a talented Senior Design Quality Engineer / Senior Supplier Quality Engineer.

• Interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management, and production and process controls.
• Lead CAPA investigations and supplier corrective actions.
• Work closely with the Operations team to define process controls, process validation requirements, and in‑process inspections.
• Collaborate with Design Quality, Supplier Quality, and Operations to ensure effective hand‑offs and communication in support of commercial products, new products, and continuous improvement activities.
• Facilitate non‑conforming material report investigation and closure, failure investigations, CAPA actions, and change control activities.

• Strong knowledge of medical device regulation and quality system requirements (ISO 13485, ISO 14971, 21 CFR Part 820).
• Experience with CAPA investigations, supplier corrective actions, and product lifecycle management.
• ASQ Certified Quality Engineer preferred.
• Excellent communication and collaboration skills.
• Ability to manage multiple priorities in a fast‑paced environment.

• Competitive base salary between $90k and $120k, depending on experience.
• 401(k) retirement plan.
• Medical, dental, and vision benefits.
• Paid time off and vacation.

Jobot is an Equal Opportunity Employer. All qualified candidates receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, or any other status protected by law.