What are the responsibilities and job description for the Quality Assurance Lead position at Atraverse Medical, Inc.?
Job Description
Atraverse Medical, Inc. is seeking a Principal Quality Engineer to develop and implement quality procedures for compliance with regulatory requirements.
The successful candidate will have experience in implementing FDA and ISO procedures resulting in facility inspection approval.
Responsibilities:
- Develop and update quality procedures for QMS and new products/processes.
- Assist in the development of new inspection and test methods.
- Provide feedback to QA, Operations, and R&D on quality issues.
- Perform gap analysis of external standards (e.g., ISO 13485).
- Develop comprehensive Risk Assessment files for new products.
- Lead supplier audits based on risk management processes.
- Create and/or review quality and regulatory documents.
Requirements:
- Bachelor's Degree in engineering or equivalent.
- Minimum 10-12 years in Quality Engineering for medical device manufacturing.
