Responsibilities

1. Develop quality testing methods, documentation, and test procedures.
2. Implement and maintain quality standards in accordance with ISO 13485 .
3. Manage quality system metrics such as Customer Complaints (CCs), Non-Conforming Material Reports (NCMRs), and Corrective and Preventive Actions (CAPA).
4. Lead and support project and sustaining activities, including test method validations, first article inspections (FAI), product inspections, and material releases.
5. Implement, review, and support Engineering Change Orders (ECOs).
6. Establish detailed quality standards and ensure compliance with organizational quality objectives.
7. Conduct and support internal, external, and customer audits.
8. Define and monitor quality metrics for manufacturing processes.
9. Supervise and manage workload of quality technicians and inspectors, as applicable.
10. Perform inspections of materials and products...