Primary Skills: cGMP compliance (advanced), ISO 9001 (advanced), CAPA investigations (advanced), Risk Management Tools (advanced)
Contract Type: W2
Duration: 12 Months
Location: Santa Clara, CA - 95054 (Onsite)
Pay Range: $40/hr - $45/hr
Job Summary: This role focuses on providing critical quality engineering support for the manufacturing, integration, and testing of specialized bioprocessing equipment. You will collaborate with various departments to ensure quality standards are met throughout project lifecycles, from initial build to final release. This position also involves hands-on problem-solving on the production floor and managing quality systems compliance.
Key Responsibilities:
- Ensure quality requirements are met during equipment build, integration, and testing phases.
- Address and resolve real-time quality issues on the production floor.
- Develop and maintain quality system documentation and processes.
- Lead investigations for deviations, nonconformances, and CAPAs.
- Monitor and analyze site quality metrics to drive continuous improvement.
Must-Have Skills:
- 4+ years of Quality Engineering experience in a regulated manufacturing environment.
- Experience with Quality Management Systems (Document Control, CAPA, Deviations, etc.).
- Ability to interpret technical documentation and schematics.
Experience in the medical device or biopharmaceutical equipment manufacturing industry is preferred.
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