Design Quality Engineer, Peabody

Job Description:

Support the design quality assurance of capital equipment medical devices through FMEA development, risk documentation, and process compliance.

Responsibilities:

Generate Design, Process, and Use FMEAs for capital equipment medical devices.

Create risk management plans and reports.

Apply structured problem-solving to identify and resolve quality issues.

Maintain QMS compliance by updating SOPs.

Support and manage CAPA activities and systems.

Requirements:

1–8 years of experience in Design Quality Engineering.

Experience with capital equipment products (hardware, electrical components).

Background in medical devices.

Degree in Mechanical, Biomedical, or Electrical Engineering.

Strong skills in FMEAs and risk management.

Direct CAPA management experience.

Familiarity with regulatory audit environments.