Senior R&D Quality Engineer – Medical Devices

Regulatory Jobs; Ohio; On-site; USD 90,000 - 130,000; Full time

Job summary

Regulatory Jobs in the United States seeks an experienced R&D Quality Engineer III to lead and enforce product development quality initiatives for medical devices, ensuring robust design and manufacturability.

You will manage risk, document control, FMEA processes, and cross-functional collaboration while mentoring junior engineers and applying Six Sigma to drive continuous improvement.

Qualifications

• Bachelor's degree in engineering or related field required.
• CQE certification preferred.
• Six Sigma Black Belt and CRE certifications preferred.
• Experience in medical device quality systems is desired.

Responsibilities

• Plans, leads, and manages quality deliverables on NPD projects per ISO and FDA requirements.
• Leads risk management processes and creates risk management documentation.
• Produces and approves PRP-related docs (change requests, test specs, design records).
• Facilitates FMEA and QM initiatives; mentors engineers; drives continuous improvement.

Skills

Quality mindset

Risk management

Team leadership

Continuous improvement

Analytical thinking

Education

Bachelor's in Engineering or related field

CQE preferred

Six Sigma Black Belt preferred

CRE preferred

Tools

Minitab

MS Office

Design of Experiments

Job description

Regulatory Jobs in the United States seeks an experienced R&D Quality Engineer III to lead and enforce product development quality initiatives for medical devices, ensuring robust design and manufacturability.

You will manage risk, document control, FMEA processes, and cross-functional collaboration while mentoring junior engineers and applying Six Sigma to drive continuous improvement.