Quality Assurance Specialist - 1st Shift

Job description

Quality Assurance Specialist I – 1st Shift DEPARTMENT: Quality: OCCUPATIONAL SUMMARY: We are seeking a high-caliber QMS Specialist to manage the lifecycle of quality events. The QA Specialist will be responsible for investigating customer complaints, processing deviations, and overseeing the change control system to ensure that all modifications to processes or products are handled without compromising quality or regulatory standing. QUALIFICATIONS: ACCOUNTABILITY: Senior Manager, Quality Assurance - Complaint Management: Process and investigate product quality complaints; perform root cause analysis (RCA) and coordinate with medical or technical teams to assess patient/user risk. - Deviation Handling: Lead the investigation of non-conformances or deviations from approved procedures; categorize severity (Minor/Major/Critical) and ensure timely closure. - Change Control Oversight: Act as a subject matter expert for the Change Control Board; review proposed changes to equipment, methods, or documentation to ensure they are justified and validated. - CAPA Integration: Ensure that complaints and deviations trigger Corrective and Preventive Actions (CAPA) when systemic issues are identi...