Senior Quality Engineer

• Fast‑Growing, Innovation‑Focused Medical Device Company
• Excellent Benefits including 100% Medical coverage for indiv and family

About Our Client

My client is driven by a mission rooted in innovation, transparency, and patient benefit, the company emphasizes excellence in design, adherence to global regulatory standards, and the development of a collaborative, talent‑focused workplace. With continued investment, substantial venture backing, and ongoing expansion of its technology platform, the organization remains at the forefront of advancing next‑generation treatment solutions for chronic heart failure

Job Description

The key responsibilities of the Senior Quality Engineer are:

• Lead risk management activities in accordance with ISO 14971 and applicable regulatory requirements (e.g., FDA, EU MDR).
• Develop, maintain, and continuously improve risk management files, including hazard analyses, FMEA/FMECA, and risk/benefit assessments.
• Ensure alignment of risk documentation with design control processes and design history files (DHFs).
• Support global regulatory submissions by providing risk management documentation.
• Ensure compliance with relevant standards and guidelines, including ISO 14971, ISO 13485, IEC 62304 (as applicable), and regulatory expectations.
• Participate in internal and external audits, including FDA and notified body inspections.

The Successful Applicant

The successful Senior Quality Engineer will have:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
• 5+ years of experience in Quality Engineering, Risk Management, or related roles within the medical device industry
• Strong working knowledge of ISO 14971 and risk management principles.
• Experience with risk analysis tools such as FMEA, fault tree analysis, and hazard analysis.
• Familiarity with design controls, CAPA systems, and post-market surveillance processes.
• Understanding of applicable regulatory frameworks (FDA 21 CFR Part 820, MDSAP).

What's on Offer

My client can offer the following:

• Full Coverage Medical Benefits - Employee + family contribution is 100%
• Paid Vacation, floating holidays, and sick time.
• Paid Holidays
• 401k Match (up to 6%)
• Annual bonus eligibility