Location: Los Angeles, CA, US
Job Summary:
Job Duties:
- Ensure compliance with global quality system regulations for active implant medical devices.
- Manage internal and external audits, quality system validation activities, and CAPA systems.
- Support the Management Review process and report to the Head of Quality Systems.
Required Skills:
- Certified lead auditor training and experience in relevant regulations (21CFR820, ISO13485, etc.).
- Strong knowledge of medical device regulatory requirements.
- Proficiency in Microsoft Word, Excel, and Access.
- Excellent problem-solving, communication, and team leadership skills.
Required Experiences:
- 5+ years in a regulated medical device environment.
- Experience in quality systems compliance auditing and CAPA management.
- Management/supervisory experience in Quality or Regulatory fields.
- B.S. in Engineering, Business Administration, or equivalent.
- Certification as Certified Quality Auditor or equivalent.
Job URLs: