What are the responsibilities and job description for the Senior Quality Assurance Engineer position at Atraverse Medical, Inc.?
About Atraverse Medical, Inc.
Atraverse Medical is an innovative medical device start-up dedicated to developing cutting-edge left-heart access technologies that enhance procedural efficiency and improve patient outcomes. Our mission is to revolutionize the field of medical devices by providing solutions that streamline procedures and elevate care standards.
The Role
We are seeking a highly skilled Principal Quality Engineer to join our team. As a key member, you will be responsible for developing, implementing, and maintaining quality procedures that ensure compliance with regulatory requirements, internal processes, and inspection documents related to Atraverse Medical's hardware.
Key Responsibilities
- Develop and update quality procedures for the Quality Management System (QMS) as well as new products and processes.
- Collaborate with cross-functional teams to develop new inspection and test methods.
- Provide expert guidance on quality issues to QA, Operations, and R&D teams.
- Assist product development team members in initiating document changes.
- Analyze external standards such as ISO 13485 to identify gaps and areas for improvement.
- Develop comprehensive risk assessments for new products and lead supplier audits based on risk management processes.
- Create and review quality and regulatory documents, including protocols, reports, test methods, inspection methods, design dossiers, submissions, and procedures.
- Submit mandatory reports to external agencies, such as MDR and vigilance reports.
- Perform risk management activities, including the development and maintenance of risk files in accordance with ISO 14971.
- Plan, document, and execute product/process validations.
- Lead internal quality system audits, including planning, execution, reporting, and corrective action plan development.
- Initiate and maintain supplier qualification activities, including supplier audits.
- Investigate and resolve nonconforming material/product issues and implement corrective actions.
