Sr Quality Engineer
2 weeks ago
Job ID: 22904
Location: 1851 E. Deere Ave, Santa Ana, CA 92705 (Onsite - Full Time)
Duration: 12 Months
Pay Rate: $55.00 - $58.00/hr (W2)
Summary:
Seeking an experienced Sr. Quality Engineer to support manufacturing, sustaining, and new product introduction activities at Medtronic's Santa Ana site. The role focuses on driving continuous improvement, managing nonconformances and CAPAs, and ensuring compliance with FDA QSR and ISO 13485 standards in a hands-on, regulated medical device environment. This position requires working onsite in controlled environments and with animal-origin tissue (bovine/porcine).
Must-Have Skills:
- Nonconformance & CAPA Management: Proven experience investigating product nonconformances, performing root cause analysis, and implementing effective corrective/preventive actions.
- Risk Management: Strong understanding of FMEA and risk assessment methodologies.
- Regulatory Compliance: Solid working knowledge of FDA QSR, ISO 13485, and validation requirements (IQ/OQ/PQ).
- Manufacturing Quality Support: Hands-on experience in production environments and cleanrooms.
- Cross-Functional Collaboration: Strong teamwork and communication skills for collaboration across engineering, production, and quality functions.
- Experience: Minimum 4+ years in Quality Engineering or related role within the medical device or regulated industry.
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