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.