Quality Engineer – Medical Devices QA Lead (Onsite)

Experis Technology Group

Temecula (CA)

On-site

USD 48,000 - 54,000

Full time

2 days ago
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Benefits offered by this job

Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account
Health Flexible Spending Account
Dependent Care Flexible Spending Array
Supplemental Life Insurance
Short Term Disability Insurance
Long Term Disability Insurance
Business Travel Insurance
Weekly Pay
401(k) Plus Match

Job summary

Experis Technology Group is seeking a Quality Engineer for 100% onsite work in Temecula, CA. The role focuses on medical device QA activities aligned with FDA QSR and ISO 13485 standards.

Responsibilities include developing inspection processes, supporting product quality throughout production, managing sterilization validations, and leading MRB and complaint investigations. Competitive W2 pay is offered.

Qualifications

  • Experience in medical device quality systems (FDA QSR)
  • Ability to develop and maintain incoming inspection processes
  • Strong capability to lead corrective actions and quality improvements
  • Experience with supplier interfaces and MRB activities

Responsibilities

  • Initiate and support QA activities per FDA QSR/ISO 13485.
  • Develop incoming inspection processes and related documentation.
  • Provide in‑process QA support including inspection and document reviews.
  • Manage sterilization process validations and sterile loads.
  • Track nonconforming material and lead MRB efforts.
  • Lead complaint investigations and failure analyses for returned products.

Skills

Quality assurance
FDA QSR
ISO 13485
Medical devices

Job description

Experis Technology Group is seeking a Quality Engineer for 100% onsite work in Temecula, CA. The role focuses on medical device QA activities aligned with FDA QSR and ISO 13485 standards.

Responsibilities include developing inspection processes, supporting product quality throughout production, managing sterilization validations, and leading MRB and complaint investigations. Competitive W2 pay is offered.

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