Mfg/Ops Quality Engineer 1
Illumina · San Diego, CA
QualityFull-time$63k–$94kCompany career page
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Role summary
Illumina seeks a Manufacturing/Operations Quality Engineer to support sustaining activities in a regulated manufacturing environment. The role involves quality oversight, compliance verification, and collaboration with engineering and manufacturing teams to ensure FDA and ISO requirements are met.
What they're looking for
- Bachelor's degree in engineering or science
- 0-2 years quality assurance experience in regulated environment
- Knowledge of 21CFR 820, ISO 13485, ISO 14971, IVDD standards
- Experience with ERP systems, SAP preferred
- Strong communication, facilitation, and negotiation skills
- Ability to adapt to fast-paced, dynamic work environment
What you'll be doing
- Provide quality engineering support throughout product lifecycle and validation activities
- Ensure adequacy of nonconformances, investigations, and corrective action records
- Review verification and validation reports for GMP compliance gaps
- Trend and analyze quality data to identify process improvement recommendations
- Coordinate with manufacturing and engineering teams on sustaining activities and change management
Privacy & handoff
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