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Sr Quality Engineer

Santa Ana, CA 92705

Posted: 01/05/2026 Employment Type: Contract Job Category: Engineering Job Number: 623784 Is job remote?: No Country: United States

Job Description

Position Overview:
As a Quality Engineer you will play a key role in ensuring that products and processes comply with regulatory and the companies standards. You’ll collaborate cross-functionally to drive continuous improvement, support manufacturing, and ensure the highest levels of product quality and patient safety. The role includes hands-on support in controlled environments, involvement with animal-origin tissue, and active participation in daily production activities.

Key Responsibilities:
• Provide quality engineering support for manufacturing, sustaining, and new product introduction.
• Participate in daily manufacturing tier meetings to support production and address quality-related concerns.
• Be present in controlled environment areas/clean rooms to monitor processes, support investigations, and ensure compliance with quality standards.
• Work with tissue from animal origin (porcine and bovine) in accordance with safety and regulatory requirements.
• Investigate product non-conformances and implement corrective and preventive actions (CAPA).
• Lead or participate in process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations.
• Review and approve process and product changes.
• Analyze data, conduct risk assessments, and support root cause analysis.
• Lead or support internal and external audits.
• Participate in the development and review of quality documentation (procedures, protocols, reports).

Minimum Requirements:
• Bachelor’s degree in Engineering, Science, or related technical field.
• 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry.
• Experience with Nonconformance material reports, CAPAs, and FMEA.
• Able to work with Bovine and Porcine tissue.
• Working knowledge of FDA regulations and ISO 13485.

Preferred Qualifications:
• Experience with CAPA, risk management (FMEA), and process validation.
• ASQ certification (CQE, CQA) a plus.
• Strong communication and teamwork skills.
• Experience with statistical analysis and data interpretation.

Pay ranges between 48-53/hr based on experience 
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About Santa Ana, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant city of Santa Ana, California, where endless possibilities await. Nestled in Orange County, Santa Ana offers a delightful blend of diverse cultures, stunning art galleries like the Bowers Museum, theaters such as the Yost Theater, and mouthwatering cuisine at the 4th Street Market. Home to the professional sports teams like the Orange County Soccer Club, this city also boasts serene parks like Santiago Park for outdoor enthusiasts. Come be a part of a community brimming with charm and growth opportunities – your dream job could be just a click away.