Overview
On Site
USD 32.00 - 40.00 per hour
Contract - Independent
Skills
Medical Devices
ROOT
Collaboration
Customer Satisfaction
Quality Control
Manufacturing
Regulatory Compliance
ISO 13485
Privacy
Marketing
Job Details
Location: Irvine, CA
Salary: $32.00 USD Hourly - $40.00 USD Hourly
Description: Our client is currently seeking a Quality Engineer I - Medical Devices
Join a dynamic team driving quality excellence in medical device manufacturing and post-market performance. As a Quality Engineer I, you'll lead root cause investigations, ensure regulatory compliance, and collaborate cross-functionally to uphold product integrity and customer satisfaction.
Key Responsibilities:
Minimum Qualifications:
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $32.00 USD Hourly - $40.00 USD Hourly
Description: Our client is currently seeking a Quality Engineer I - Medical Devices
Join a dynamic team driving quality excellence in medical device manufacturing and post-market performance. As a Quality Engineer I, you'll lead root cause investigations, ensure regulatory compliance, and collaborate cross-functionally to uphold product integrity and customer satisfaction.
Key Responsibilities:
- Develop and implement quality control plans to maintain manufacturing continuity and product conformance
- Lead investigations into production and customer complaints, driving corrective and preventive actions
- Analyze product performance using statistical and risk-based methods
- Troubleshoot returned devices and nonconformities, documenting findings and resolutions
- Communicate complex technical issues across diverse teams
- Ensure compliance with FDA regulations (21 CFR Part 820 & 803), ISO 13485, and global standards
Minimum Qualifications:
- Bachelor's degree in Engineering
- 2+ years in a regulated industry (FDA environment preferred)
- Strong knowledge of FDA regulations and ISO 13485
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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