Sr Quality Engineer

Job Title:
Sr Quality Engineer
Job

Location:

Irvine California 92618
Duration: 12 Months
Pay range: $/hr. on W2

Role Summary:
Senior Quality Engineer supporting manufacturing 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.

• Support and maintain manufacturing quality standards, procedures, and protocols.
• Troubleshoot process/equipment issues and perform root cause investigations.
• Lead CAPA and NCMR investigations and corrective actions.
• Perform process V&V and develop/execute IQ, OQ, PQ protocols.
• Perform Test Method Development & Validation (TMV).
• Conduct risk management/FMECA, including DFMECA and PFMECA.
• Use 5 Whys, 6M, Fishbone/Ishikawa, Pareto for root cause analysis.
• Perform statistical analysis including process capability, MSA, tolerance analysis, and Minitab.
• Apply Lean/Six Sigma and process control techniques.
• Develop/review manufacturing documentation, specifications, procedures, and sampling methods.
• Collaborate with Production, Manufacturing Engineering, R&D, Quality, and Regulatory teams.
• Provide guidance/training to junior Quality Engineers and technicians.