Sr Quality Engineer - Exempt

LanceSoft Inc

Santa Ana, CA

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JOB DETAILS

JOB TYPE

Full-time

LOCATION

Santa Ana, CA

POSTED

19 days ago

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 Overview 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. 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. Location Santa Ana, CA (onsite)

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Sr Quality Engineer - Exempt

LanceSoft Inc

Santa Ana, CA

About the Company

LanceSoft Inc

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