- Qualify and manage suppliers for OEM/custom materials and components
- Ensure compliance with FDA and global regulatory standards
- Support supplier audits, validation, and risk management activities
- Develop and validate inspection/test methods for incoming quality
- Drive root cause investigations (NCR, CAPA, SCAR) and corrective actions
- Support Design Development File and design control requirements
- Apply statistical and quality engineering tools (dFMEA, Gage R&R, RCA)
- Bachelor's degree in Engineering or related Scientific field
- 2+ years of experience in Supplier Quality, Manufacturing, or Quality Engineering
- Experience in a highly regulated industry (Medical Device preferred)
- Experience with Class II or Class III medical devices
- Knowledge of FDA & international medical device regulations
- Experience conducting supplier/vendor audits
- Strong problem-solving and statistical analysis skills
- Six Sigma/Lean or ASQ certification (CQE/CQA) preferred
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Supplier Quality Engineer - Irvine - Intellectt Inc
Description
Supplier Quality Engineer II (Onsite – 80%+) in Irvine, CA
Travel: Up to 25% (domestic & international)
Position Overview
The Supplier Quality Engineer II will support design and development teams in qualifying critical materials and suppliers for innovative, life-saving medical devices. This role ensures supplier compliance with internal and regulatory requirements while collaborating cross-functionally with R&D, Operations, Quality, Sourcing, and Regulatory Affairs.
Key Responsibilities
Required Qualifications
Preferred Qualifications
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine, California, United States
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Quality Engineer
Only for registered members Irvine, CA
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Quality Engineer
Only for registered members Irvine
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Quality Engineer
Only for registered members Irvine
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Quality Engineer
Only for registered members Irvine