Sr Quality Engineer Exempt

Join our team in Santa Ana CA a vibrant location known for its rich culture and proximity to beautiful Southern California beaches. As a key member of our Quality Engineering team you will play a crucial role in ensuring the highest standards of product quality and patient safety in the medical device industry.

As a Quality Engineer at our Santa Ana facility you will collaborate cross-functionally to drive continuous improvement support manufacturing and ensure compliance with regulatory standards. Your role will involve hands-on support in controlled environments working with animal-origin tissue and active participation in daily production activities.

• 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).

• Bachelors 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.

• 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.

Santa Ana CA (onsite)