What are the responsibilities and job description for the Regulatory Compliance Lead - Medical Devices position at Atraverse Medical, Inc.?
Atraverse Medical, Inc. is a cutting-edge medical device company developing innovative technologies to improve patient outcomes. We are seeking a highly experienced Principal Quality Engineer to join our team.
About the Position
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.
Duties and Responsibilities
- Develop and update quality procedures for QMS and new products/processes
- Assist in the development of new inspection and test methods
- 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
Why Work with Us?
- Opportunities for professional growth and development
- Dynamic and diverse work environment
- Competitive salary and benefits package
