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