Sr. Quality Engineering, Manufacturing

The Role

The Senior Quality Engineer (SQE) will serve as the immediate delegate to the Quality Manager. Ensure that the quality standards of the company remain maintained within the SGLS Garden Grove procedures, policies, purchased components and manufactured products. Participate in and lead complaint investigations, CAPA investigations, lead supplier audits, drive supplier quality, conduct internal audits and drive continuous improvement projects throughout the plant. Support any facility expansions, software validations, equipment qualifications and / or process validations required to support existing / new processes. Participate in and host third party audits and conduct training when needed.

Implementation, maintenance and control of systems & practices, which monitor, assess, and approve the quality of materials and products at all stages of production. Support the implementation of continuous quality improvement objectives, primarily cGMP and ISO standards for the manufacturing location. Ensure the plant remains in full compliance with regulatory requirements and ISO requirements as they pertain to the plant, customer specifications, and corporate quality policies.

Requirements

• Bachelor’s Degree in Engineering (required)
• Master’s Degree in Mechanical, Chemical or Industrial Engineer (preferred)
• 5+ years experience Plastics, Machining, and/or Injection Molding Operations
• Analytics, Project management (Required)
• Lead Auditor and ISO: ASQ (CQE, CQM, CQA) certification (Required)
• WCM or Six Sigma Greenbelt (Preferred)