Senior Quality Engineer - Medical Devices (Onsite)

MiniMed; Los Angeles (CA); On-site; USD 97,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

STI eligibility

Job summary

MiniMed is seeking a Senior Quality Engineer to drive quality standards across our manufacturing operations. You will design inspection mechanisms, lead process validation, and ensure products meet FDA, ISO 13485 and 21 CFR Part 820 standards.

You’ll partner with Engineering and Manufacturing to build robust controls and reduce variation in a highly regulated environment. The role emphasizes root-cause analysis, CAPA, and real-time guidance on deviations, with a focus on patient safety and

Qualifications

• Bachelor’s degree in engineering, science or technical field with 4+ years of experience.
• Advanced degree in engineering/science with 2+ years of experience in Engineering and/or Quality.

Responsibilities

• Develops and maintains quality standards for processing materials to finished products.
• Plans, executes validation protocols (IQ/OQ/PQ) and reports results.
• Supports CAPA, non-conformance and deviation management with root-cause analysis.
• Collaborates with Engineering and Manufacturing to ensure robust process controls across lifecycle.
• Authors validation protocols, technical reports and quality documentation.

Skills

Quality assurance

Process validation

Root cause analysis

Statistical methods

Documentation

Education

Bachelor’s degree in engineering/science/technical field

Advanced degree in engineering/science/technical field

Tools

TMV

Gauge R&R

MSA

Job description

MiniMed is seeking a Senior Quality Engineer to drive quality standards across our manufacturing operations. You will design inspection mechanisms, lead process validation, and ensure products meet FDA, ISO 13485 and 21 CFR Part 820 standards.

You’ll partner with Engineering and Manufacturing to build robust controls and reduce variation in a highly regulated environment. The role emphasizes root-cause analysis, CAPA, and real-time guidance on deviations, with a focus on patient safety and