What are the responsibilities and job description for the Medical Device Quality Assurance Specialist position at Atraverse Medical, Inc.?
Atraverse Medical, Inc. is an innovative medical device start-up 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 Opportunity
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.
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
- Lead supplier audits based on risk management processes
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
Benefits
- Health, Dental, and Vision benefits for full-time employees
