Senior RPA QA Engineer - Medical Device Compliance & CAPA

BrioHealth Solutions; Burlington (VT); On-site; USD 80,000 - 100,000; Full time

Job summary

A global Med-Tech company is seeking a Returned Product Analysis Quality Engineer to drive quality assurance for implantable medical devices. This mid-senior level role focuses on compliance, complaint handling, and continuous improvement initiatives. The ideal candidate will have over 7 years of experience in medical device quality engineering and a strong background in failure analysis. This full-time position offers the opportunity to make a significant impact on product safety and performance.

Qualifications

• 7+ years of experience in medical device quality engineering.
• Hands-on experience with failure analysis for medical devices.
• Experience with implantable medical devices and complaint handling.

Responsibilities

• Lead device history reviews and investigations.
• Collaborate with teams to implement corrective actions.
• Drive continuous improvement in complaint handling.

Skills

Failure analysis techniques

Regulatory requirements understanding

Analytical skills

Problem-solving skills

Technical writing skills

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or Science

Job description

A global Med-Tech company is seeking a Returned Product Analysis Quality Engineer to drive quality assurance for implantable medical devices. This mid-senior level role focuses on compliance, complaint handling, and continuous improvement initiatives. The ideal candidate will have over 7 years of experience in medical device quality engineering and a strong background in failure analysis. This full-time position offers the opportunity to make a significant impact on product safety and performance.