What are the responsibilities and job description for the Principal Quality Assurance and Regulatory Expert position at Atraverse Medical, Inc.?
Atraverse Medical, Inc. is a leader in medical device innovation, developing flexible left-heart access technologies to streamline procedures and improve patient outcomes. We are seeking a highly experienced Principal Quality Engineer to join our team.
About the Job
This role will be responsible for ensuring that our medical devices meet regulatory requirements, including FDA and ISO standards. The successful candidate will develop and implement quality procedures, lead supplier audits, and participate in design review meetings.
We are looking for someone with a strong background in quality engineering, preferably in the medical device industry. Experience with implementing FDA and ISO procedures is essential, as well as familiarity with inspection and testing techniques.
The ideal candidate will have excellent written and oral communication skills, as well as strong intra-personal skills. They will also have the ability to lead quality circles for process improvement and problem-solving.
Atraverse Medical offers a dynamic and diverse work environment, with opportunities for professional growth and development.
Key Performance Indicators
- Successful implementation of quality procedures
- Effective leadership of supplier audits
- Participation in design review meetings
Requirements
- Bachelor's Degree in engineering-related field or equivalent
- Minimum 10-12 years in Quality Engineering for medical device manufacturing
- Experience with implementing FDA and ISO procedures resulting in facility inspection approval
