Location: Danvers, MA
Job Summary:
Job Duties:
- Lead Design Quality Engineering for Software Product Development.
- Ensure compliance with IEC 62304 and IEC 82304-1.
- Support product security processes.
- Apply FDA regulatory knowledge to risk management and testing.
- Participate in design reviews and approve related artifacts.
- Review and approve Engineering Change Orders (ECO).
- Execute Quality functions per FDA QSRs and ISO standards.
- Develop and implement product assurance plans.
- Ensure compliance of computerized quality systems.
- Build interpersonal relationships within and outside the company.
Required Skills:
- Design quality engineering
- Risk assessment
- Regulatory compliance (FDA, ISO)
- Software development
- Test method development
- Interpersonal skills
Required Experiences:
- Software as a Medical Device (SaMD)
- Medical Device Data Systems (MDDS)
- Quality system regulations
- Design controls
- Product assurance
Job URLs: