Senior Quality Engineer - Medical Device Manufacturing

$110,000 - $120,000/Yr

Jobot - Monrovia, CA

Full-time - Mid Level

Monrovia, CA

Administrative and Support Services

About the position

The Senior Quality Engineer plays a crucial role in ensuring the quality and compliance of medical device manufacturing processes. This position involves supporting process quality and testing improvement activities, coordinating Good Manufacturing Practices (GMP) activities, and ensuring that products are tested and released in accordance with project timelines. The role requires a strong focus on investigating nonconformance issues, leading corrective actions, and supporting regulatory filings.

Responsibilities

• Investigate manufacturing nonconformance's, product or component failures, customer complaints, or product returns.
• Lead or participate in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis.
• Determine root cause and recommend Corrective and Preventive Actions (CAPA).
• Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.
• Support supplier qualification activities and Supplier Change Requests (SCRs) with appropriate departments.
• Support regulatory filings including NDA, annual reports, and other documents for filings.
• Provide guidance and leadership on design process characterization studies (DOE, R&R).
• Conduct statistical analysis of results to identify critical parameters and improve process capability.

Requirements

• Bachelor's degree, preferably in Engineering or Sciences.
• 5+ years experience in validation and/or quality engineering.
• General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization.
• Technical Writing & Reporting for compliance and/or validation/quality assurance.

Nice-to-haves

• Advanced degree preferred.
• Certified Quality Engineer (CQE) or equivalent preferred.

Benefits

• Competitive Pay
• Growth potential
• Work with a great team