Senior Quality Engineer — MedTech Process & Compliance Lead

USA-Medtronic MiniMed, Inc 1017

Los Angeles (CA)

On-site

USD 97,000 - 165,000

Full time

2 days ago
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Benefits offered by this job

Health, dental, and vision insurance
401(k) with company match
Short-term incentive (STI)
Employee Stock Purchase Plan

Job summary

MiniMed is seeking a Senior Quality Engineer to lead quality authority across manufacturing, drive process validation, and ensure products meet stringent safety standards. You will design inspection methods, conduct TMV/MSA/DOE studies, and collaborate with Engineering and Manufacturing to reduce variation and enhance patient safety.

The role anchors on FDA/ISO 13485/21 CFR 820 compliance, combines analytical rigor with hands-on floor support, and offers a path to impact life-changing medical

Qualifications

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

Responsibilities

  • Develops, maintains, and improves quality standards and protocols across manufacturing operations.
  • Plans, implements, and validates inspection, testing, and measurement methods.
  • Performs root cause analyses and CAPA to resolve deviations and nonconformances.
  • Supports IQ/OQ/PQ process validation and new manufacturing line launches.

Skills

Quality engineering
Root cause analysis
Statistical analysis
Documentation

Education

Bachelor’s degree in Engineering/Science or technical field
Advanced degree in Engineering/Science (optional)

Tools

TMV
MSA
SPC
DOE

Job description

MiniMed is seeking a Senior Quality Engineer to lead quality authority across manufacturing, drive process validation, and ensure products meet stringent safety standards. You will design inspection methods, conduct TMV/MSA/DOE studies, and collaborate with Engineering and Manufacturing to reduce variation and enhance patient safety.

The role anchors on FDA/ISO 13485/21 CFR 820 compliance, combines analytical rigor with hands-on floor support, and offers a path to impact life-changing medical

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