Location: Danvers, MA, 01923, US
Job Summary:
Job Duties:
- Lead Design Quality Engineering for Software Product Development and Life Cycle processes.
- Conduct risk assessments and support design controls.
- Ensure compliance with IEC 62304 and IEC 82304-1.
- Participate in design reviews and approve engineering change orders.
- Collaborate with Manufacturing, Engineering, and IT on quality systems.
Required Skills (Keywords):
- Quality engineering
- Risk management
- FDA regulations
- IEC 62304
- ISO 13485
- TIR45
- Agile methodologies
Required Experience (Topics):
- 8 years of quality experience
- 5 years in medical device industry
- Class III medical device experience preferred
Job URLs: