Operations Quality Engineer
$75,000–$120,750 year
On-site · San Jose, California, United States
Job Summary
Lead, conduct and complete investigations of nonconformances; manage site nonconformance metrics; document and track material disposition; support calibration program and verification of timely calibration; review calibration records; assist root-cause analysis and CAPA effectiveness; support process validation, control, and risk management; champion compliance with global regulations and standards; collaborate with multi-functional teams; ensure audit-ready records and support internal/external audits. Strong foundation in quality systems, metrology, CAPAs, audits, calibration, PM activities, and regulatory requirements within a manufacturing environment.
Required Qualifications
- Bachelor’s degree or equivalent experience in Engineering, Science, or a related technical field
- Basic understanding of quality management systems and regulatory requirements (e.g., ISO 13485, FDA QSR)
- Experience with CAPAs non-conformances, audits, and process validation
- Knowledge of basic statistical tools and quality improvement methodologies
- Experience supporting equipment calibration, preventive maintenance, or metrology systems
- Experience in Quality Engineering or Quality Assurance of a regulated medical devices or other regulated industries
- Ability to work multi-functionally in a manufacturing environment
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