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ISO 13485

Cross-functional communication FDA regulations Senior leadership Full Job Description Are you a seasoned, Medical Device , Quality professional ready to take ownership of a company's Quality Management System and make a meaningful impact? We are working with a global Medical Device leader in reproductive technology, providing innovative medical devices, laboratory products, equipment, and solutions that support fertility clinics and IVF laboratories around the world. Our client is looking for a Senior Quality System Manager with Medical Device experience to lead Quality Systems strategy, compliance, and continuous improvement within a highly regulated medical device environment. This is an exciting opportunity for a hands-on Quality leader who can bring strong regulatory expertise, develop a high-performing team, and partner cross-functionally with Manufacturing, Engineering, and other key business areas. The Medical Device Senior Quality Systems Manager will: Lead and oversee the company's Quality Management Systems, including CAPA, document control, final product release, change notifications, and quality-related activities. Serve as a trusted Quality resource for GMP, ISO, and medical device regulatory requirements. Lead preparation for and support FDA, Notified Body, and other regulatory inspections. Coordinate and host internal and external audits, driving timely and effective responses. Identify opportunities for continuous improvement across products, processes, and Quality Systems. Analyze Quality and business KPIs, identify trends, and develop corrective and preventive action strategies. Provide Quality Systems training, coaching, and guidance throughout the organization. Lead, mentor, and develop the Quality Systems team, including hiring, goal setting, performance management, and professional development. Partner with cross-functional teams on quality, manufacturing, engineering, and project management initiatives. Apply strong problem-solving and root cause analysis skills to identify risks and drive sustainable solutions.

Requirements:

Bachelor's degree preferred. 10+ years of Quality Systems experience in a regulated environment, with 3+ years of management experience and 2+ years of project management experience. Strong experience within a regulated medical device manufacturing environment. Working knowledge of applicable U.S. and international medical device regulations, including 21 CFR 820, 21 CFR 803/804, ISO 13485, ISO 14971, ISO 13408, EU MDR 2017/745, and other applicable global requirements. Experience with internal/external auditing; formal auditor training or certification is a plus. Experience with process and equipment validation, method validation, process investigations, and technical evaluations preferred. Knowledge of quality tools such as Root Cause Analysis, FMEA, FTA, DOE, risk assessment, statistical techniques, and Six Sigma/CQE/CQA methodologies is a plus . Strong analytical, organizational, communication, and interpersonal skills. Confident representing the Quality function and providing guidance across Manufacturing, Engineering, and other functional teams. Ability to thrive in a fast-paced environment, manage multiple priorities, and maintain a positive, solutions-focused approach. Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook. Why This Opportunity? This is more than a Quality Systems management role; it's an opportunity to shape and strengthen the quality culture of a growing medical device organization. You'll have leadership responsibility, cross-functional exposure, and influence to make a measurable difference in quality, compliance, and operational excellence.

Location :

Irvine, CA Position Type :

Direct Hire Salary :

$150,000-$175,000

Benefits :

Medical, Dental, Vision, Flexible Spending Account, Dependent Care Account, Short- and Long-Term Disability Insurance, Life Insurance, 401k, PTO & Bonus.

Pay:

$150,000.00 - $175,000.00 per year

Benefits:

401(k) Dental insurance Paid time off Vision insurance Application Question(s): Do you possess working knowledge of applicable U.S. and international medical device regulations, including 21 CFR 820, 21 CFR 803/804, ISO 13485, ISO 14971, ISO 13408, EU MDR 2017/745, and other applicable global requirements.

Work Location:

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Find & Apply For Clinical Quality Manager Jobs in Santa Ana, California

Senior Quality Systems Manager