Senior Quality Engineer - Medical Devices & Compliance

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

MiniMed is seeking a Senior Quality Engineer in Los Angeles to drive quality standards across manufacturing, validate processes, and ensure patient safety. You will lead inspection methods, conduct rigorous testing, and collaborate with Engineering and Manufacturing to implement robust controls.

The role requires deep knowledge of FDA, ISO 13485, and 21 CFR Part 820, with 4+ years of engineering/quality experience. On-site duties emphasize continuous improvement and compliant documentation.

Qualifications

• Bachelor's degree in Engineering, Science, or technical field with 4+ years of work experience in Engineering and/or Quality.
• Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality acceptable.
• Experience in FDA, ISO 13485, and 21 CFR Part 820 regulated environments preferred.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocols for processing materials into finished products, ensuring compliance with FDA, ISO 13485, and 21 CFR Part 820 requirements.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place and continuously improved across the production lifecycle.
• Plans, 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.
• Support end-to-end process validation (IQ/OQ/PQ) activities including protocol development, execution, and formal reporting in alignment with regulatory requirements.
• Develops and validates test methods (TMV ) including gauge R&R, measurement system analysis (MSA), accuracy, precision, and linearity studies to ensure reliable and reproducible results.
• Applies statistical tools such as SPC, DOE, and capability studies to identify trends, reduce variation, and drive continuous quality improvements.
• Authors and reviews validation protocols, technical reports, and quality documentation to support manufacturing and new product launches.
• Supports CAPA, non-conformance, and deviation management processes by performing thorough root cause analysis and implementing effective corrective actions.
• Serves as a quality resource on the manufacturing floor, providing guidance on process deviations and non-conformances in real time.
• Partners with cross-functional teams to implement new manufacturing lines by establishing robust process controls, defining critical quality attributes, and ensuring lines are validated and production-ready prior to full-scale launch.

Skills

Root cause analysis

Quality systems

Cross-functional collaboration

Statistical analysis

Education

Bachelor's degree in Engineering/Science/Technical field

Tools

SPC

DOE

MSA

IQ/OQ/PQ

Job description

MiniMed is seeking a Senior Quality Engineer in Los Angeles to drive quality standards across manufacturing, validate processes, and ensure patient safety. You will lead inspection methods, conduct rigorous testing, and collaborate with Engineering and Manufacturing to implement robust controls.

The role requires deep knowledge of FDA, ISO 13485, and 21 CFR Part 820, with 4+ years of engineering/quality experience. On-site duties emphasize continuous improvement and compliant documentation.