What are the responsibilities and job description for the Senior Quality Systems Engineer position at Atraverse Medical, Inc.?
We are seeking a highly experienced Principal Quality Engineer to join our team at Atraverse Medical, Inc. This role will be responsible for ensuring that our medical devices meet regulatory requirements, including FDA and ISO standards.
About the Role
The successful candidate will develop and implement quality procedures, lead supplier audits, and participate in design review meetings. They will also provide feedback to QA, Operations, and R&D on quality issues and assist in the development of new inspection and test methods.
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 Responsibilities
- Develop and maintain procedures for compliance to regulatory requirements
- Develop and implement systems to improve detection and prevention of quality failures
- Provide guidance and training to Quality personnel and employees regarding the Quality System
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
What You Will Do
- Develop, implement, and maintain procedures for compliance to regulatory requirements
- Analyze nonconforming product/process/material issues and provide solutions
- Participate in Quality planning, facilities, and products: requirements, documentation, and completion (overview/monitoring)
