More jobs:
Sr Quality Engineer - Exempt
Job in
Santa Ana, Orange County, California, 92701, USA
Listed on 2026-08-05
Listing for:
LanceSoft
Full Time
position Listed on 2026-08-05
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Quality Engineer
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.
Position OverviewAs 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.
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).
- 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.
- 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)
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