Job Summary

Manufacturing Quality Engineer at Northridge site.

Key Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Leads quality engineering activities in support of new product introduction (NPI), including design transfer, process validation, and launch readiness assessments, to ensure a smooth transition from development to full-scale manufacturing in compliance with regulatory and quality requirements.
• Proactively identifies, evaluates, and mitigates quality risks across the manufacturing process utilizing risk management tools such as FMEA, Control Plans, and ISO 14971 frameworks to prevent quality escapes and minimize impact to production schedules and customer deliverables.
• Develops, executes, and maintains test method validations (TMV) including method development, qualification, and revalidation activities to ensure measurement systems are accurate, reliable, and compliant with applicable regulatory standards and internal quality requirements.

Skill Requirements

Must Have: Minimum Requirements 

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree with 7+ years’ relevant experience, or Advanced degree with 5+ years of experience.

Other Requirements

• Proficiency in statistical analysis tools such as Minitab or equivalent, with hands-on experience applying statistical process control (SPC), Design of Experiments (DOE), and data-driven problem-solving methodologies to drive quality improvements in a high-volume manufacturing setting.
• Proven experience in Corrective and Preventive Action (CAPA) ownership, including the ability to lead end-to-end CAPA investigations, perform thorough root cause analyses using methodologies such as 8D, Fishbone, and 5-Why, and drive timely, sustainable corrective actions to closure in compliance with regulatory requirements.