Sr Quality Engineer

Job Title: Sr Quality Engineer
Job ID: 27426
Location: Irvine California 92618
Duration: 12 Months
Pay range: $55.00-60.00/hr. on W2

Role Summary:
Senior Quality Engineer supportingmanufacturing quality for Neurovascular medical devices such as coils, stents, catheters, balloons, aspiration devices, coatings, and guide wires. Responsible for process quality, validation, risk management, CAPA, NCMR, root cause investigations, and regulatory compliance.

Key Responsibilities

• Support and maintainmanufacturing quality standards, procedures, and protocols.
• Troubleshootprocess/equipment issues and perform root cause investigations.
• LeadCAPA and NCMR investigations and corrective actions.
• Performprocess V&V and develop/executeIQ, OQ, PQ protocols.
• PerformTest Method Development & Validation (TMV).
• Conductrisk management/FMECA, includingDFMECA and PFMECA.
• Use5 Whys, 6M, Fishbone/Ishikawa, Pareto for root cause analysis.
• Perform statistical analysis includingprocess capability, MSA, tolerance analysis, and Minitab.
• ApplyLean/Six Sigma and process control techniques.
• Develop/review manufacturing documentation, specifications, procedures, and sampling methods.
• Collaborate withProduction, Manufacturing Engineering, R&D, Quality, and Regulatory teams.
• Provide guidance/training to junior Quality Engineers and technicians.