Senior Quality Engineer - Design (Med Devices, Onsite)

Pragmatic; Bedford (MA); On-site; USD 120,000 - 140,000; Full time

Job summary

A growing medical device company is seeking a Senior Quality Engineer to lead design quality for new product development. This role requires collaboration with R&D and engineering to ensure compliance with regulatory standards like FDA and ISO 13485. Ideal candidates have a Bachelor's degree and 4+ years of experience in medical device quality. Strong skills in design controls and risk management are essential, along with excellent communication abilities. This full-time position is based in Bedford, MA, requiring 4 days onsite.

Qualifications

• 4+ years of medical device quality experience.
• Strong experience with design controls.
• Comfortable working cross-functionally with R&D and Engineering.

Responsibilities

• Act as the Quality lead on design and development projects.
• Own and support design controls, including risk management.
• Conduct internal and external audits.

Skills

Design controls

Risk management (FMEA, hazard analysis)

Verification and validation

Strong communication skills

Problem-solving skills

Education

Bachelor’s degree in Engineering, Science, or related field

Tools

FDA regulations

ISO 13485

EU MDR

Job description

A growing medical device company is seeking a Senior Quality Engineer to lead design quality for new product development. This role requires collaboration with R&D and engineering to ensure compliance with regulatory standards like FDA and ISO 13485. Ideal candidates have a Bachelor's degree and 4+ years of experience in medical device quality. Strong skills in design controls and risk management are essential, along with excellent communication abilities. This full-time position is based in Bedford, MA, requiring 4 days onsite.