Senior Quality Assurance Manager in Irvine

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Job DescriptionJob Description

Join a globally recognized healthcare innovator that’s redefining what’s possible in medical technology. As a Senior Quality Assurance Manager, you’ll take the lead in advancing world-class quality systems that directly shape the future of patient health and safety worldwide.

This is your opportunity to step into a high-impact leadership role where you’ll guide a talented Quality team, drive excellence across operations, and play a pivotal role in maintaining our reputation for precision, integrity, and innovation.

What You’ll Lead:
You’ll own and elevate our core Quality Systems, including the Quality Assurance and Technical Investigations Group (TIG). Your leadership will ensure every product meets the highest global standards — because every patient deserves nothing less.

Key Focus Areas:

• Final Product Release & Compliance Oversight
• CAPA Programs & Continuous Improvement
• QMS Document Control & Validations
• Internal & External Audits
• Complaints, Change Notifications & Non-Conformances

Your Mission & Responsibilities:

• Manage all aspects of Quality Systems to ensure compliance, efficiency, and continuous improvement.
• Serve as a key authority on GMP and ISO standards, providing leadership and direction to cross-functional teams.
• Direct and host FDA and Notified Body inspections, ensuring flawless audit outcomes.
• Identify and implement process, product, and quality system enhancements across global operations.
• Deliver training and mentorship on Quality System Regulations, ISO standards, and best practices.
• Build and empower your team through hiring, mentoring, and professional development.
• Track and analyze KPIs, lead effective CAPA strategies, and report measurable improvements to leadership.

What you Bring:

• Bachelor’s Degree (Science, Engineering, or related field).
• Minimum 1 year of Auditor experience .
• Proven experience within a regulated medical device manufacturing environment. 
• Deep understanding of U.S. and international medical device regulations: 21 CFR 820, 803, 804 (MDR), ISO 13485, ISO 14971, ISO 13408, EU MDR 2017/745 / MDD 93/42/EEC, and Canadian/Brazilian MDR.
• Formal training in quality tools (CQE, CQA, Six Sigma, Risk Assessment, FMEA, FTA, DOE, Statistical Techniques).
• Hands-on experience with process/equipment validation, method validations, and technical investigations.

Why You Will Love It Here:
At this company, you won’t just manage processes — you’ll shape the quality culture of a global leader committed to scientific excellence and patient well-being. You’ll have a seat at the table where innovation meets purpose, and where your voice, ideas, and leadership truly make an impact.

Company DescriptionWe operate in the assisted-reproductive technology (ART) sector, helping bring new life and hope to families. That kind of purpose can be deeply motivating from a career standpoint.Company DescriptionWe operate in the assisted-reproductive technology (ART) sector, helping bring new life and hope to families. That kind of purpose can be deeply motivating from a career standpoint.

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.