Senior Quality Engineer

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Root cause analysis

Quality systems

Cross-functional collaboration

Statistical analysis

Ausbildung

Bachelor's degree in Engineering/Science/Technical field

Tools

SPC

DOE

MSA

IQ/OQ/PQ

Jobbeschreibung

We anticipate the application window for this opening will close on - 30 Oct 2026

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

At MiniMed, every product we build has one purpose - to help people living with diabetes live healthier, safer, and more fulfilling lives. As a Senior Quality Engineer on our team, you will be at the heart of making that possible.

In this high-impact role, you will serve as a critical quality authority across our manufacturing operations - developing and maintaining quality standards, driving process validation, and ensuring every product that leaves our facility meets the highest standards of precision, compliance, and patient safety. From designing inspection mechanisms and executing test method validations to leading root cause analysis and supporting new manufacturing line launches, your expertise will touch every stage of the production lifecycle.

You will collaborate closely with Engineering, Manufacturing, and cross-functional teams to build robust process controls, reduce variation, and champion a culture of continuous improvement - all within a highly regulated environment governed by FDA, ISO 13485, and 21 CFR Part 820 requirements.

This is not just a quality role - it is an opportunity to directly influence the safety and reliability of life-changing medical technology.

If you are a detail-driven, analytically minded quality professional who thrives at the intersection of science, compliance, and collaboration - we want to hear from you.

Responsibilities may include the following and other duties may be assigned.

On Site Role

• Develops, modifies, applies and maintains quality standards and protocols for processing materials into partially finished or 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

Must Have: Minimum Requirements

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

Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

Nice to Have:

• Experience with root cause analysis methods (Fishbone, 5 Whys, Is or Is Not?)
• Ability to communicate technical knowledge to other engineers as part of a large collaborative work environment
• Ability to manage multiple projects and activities
• Strong communication skills
• Willingness to learn and adapt to new challenges on a broad spectrum of topics

#BetterDaysStartNow

#BetterDaysStartNow

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Res