Role Overview for Chief Quality Officer with a Global Medical Device Co. – Irvine, CA
JRG Partners has been exclusively retained to identify a visionary and strategic Chief Quality Officer (CQO) for our client, a pioneering global medical device company headquartered in the vibrant tech hub of Irvine, California. This is a paramount executive leadership position for an individual driven to embed a culture of unparalleled quality into the DNA of an organization that is transforming patient outcomes worldwide. As the CQO, you will be the ultimate authority on global quality and regulatory compliance, reporting directly to the Chief Executive Officer and serving as a key member of the executive leadership team.
This is not merely a role of oversight; it is a call to architect the future of quality for a company at the forefront of medical innovation. You will be entrusted with the strategic direction and operational execution of all aspects of the Quality Management System (QMS) across a diverse portfolio of life-saving and life-enhancing medical devices.
Your leadership will ensure that every product, from conception to post-market surveillance, not only meets but exceeds the most stringent global regulatory standards. You will be the champion of the customer, the guardian of patient safety, and the driver of continuous improvement initiatives that solidify the company’s reputation for excellence. We are seeking a transformative leader who can inspire a global team, navigate the complexities of international regulations, and leverage quality as a strategic competitive advantage in a dynamic market.
Based in Irvine, you will lead a multi-disciplinary, international team of dedicated quality and regulatory professionals. Your influence will extend across all functions of the organization, including R&D, manufacturing, supply chain, and commercial operations. This role demands a unique blend of deep technical expertise, exceptional business acumen, and inspirational leadership. If you are a seasoned quality executive with a passion for innovation and a proven track record of building world-class quality organizations in the medical device sector, we invite you to explore this career-defining opportunity.
Key Responsibilities of Chief Quality Officer with a Global Medical Device Co. – Irvine, CA
The Chief Quality Officer will have a broad and impactful scope of responsibilities, including but not limited to the following:
Strategic Leadership & Vision
Develop, articulate, and execute a comprehensive global quality and regulatory strategy that aligns with the company’s overall business objectives, growth plans, and long-term vision. Serve as the primary quality advocate and expert on the executive team, providing critical insights and guidance on compliance, risk, and quality-related matters to the CEO and Board of Directors.
Global Regulatory Compliance
Ensure unwavering compliance with all applicable global medical device regulations and standards. This includes mastery of the FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485, EU Medical Device Regulation (MDR), and other international requirements (e.g., Health Canada, TGA, PMDA). Act as the primary liaison with regulatory agencies during inspections and audits, fostering positive and transparent relationships.
Quality Management System (QMS) Excellence
Assume full ownership of the global QMS, ensuring its effectiveness, efficiency, and continuous improvement. Oversee all elements of the QMS, including but not limited to CAPA (Corrective and Preventive Action), document control, change control, internal and external audits, management reviews, and training programs. Drive the integration of QMS processes across all global sites and functions.
New Product Development & Lifecycle Management
Partner closely with R&D and engineering teams to embed quality principles (Design Controls) into the entire product development lifecycle, from initial concept to commercialization. Provide strategic guidance on regulatory pathways for new products, including 510(k), De Novo, and PMA submissions.
Operational & Manufacturing Quality
Oversee all quality assurance activities related to manufacturing, including process validation, supplier quality management, non-conforming material control, and batch release. Implement robust quality metrics and KPIs to monitor performance, identify trends, and drive data-driven improvements in product quality and process efficiency.
Post-Market Surveillance & Vigilance
Lead the company’s post-market surveillance, complaint handling, and vigilance reporting systems. Ensure timely investigation of product complaints and field events, and effective communication with regulatory authorities as required. Utilize post-market data to fuel continuous product and process improvement initiatives.
Team Leadership & Development
Lead, mentor, and develop a high-performing global team of quality assurance and regulatory affairs professionals. Foster a culture of accountability, collaboration, and continuous learning. Structure the organization and allocate resources effectively to meet the evolving needs of the business.
Risk Management
Champion a proactive, risk-based approach to quality management throughout the organization, ensuring compliance with ISO 14971. Oversee the development and maintenance of comprehensive risk management files for all products.
Requirements for the Chief Quality Officer with a Global Medical Device Co. – Irvine, CA
The ideal candidate will be an accomplished executive with a distinguished career in medical device quality and regulatory affairs.
Educational Background
A minimum of a Bachelor of Science (B.S.) degree in Engineering, Life Sciences, or a related technical field is required. An advanced degree (M.S., M.B.A., or Ph.D.) is highly preferred.
Executive Experience
A minimum of 20 years of progressive experience in the medical device industry, with at least 10 years in a senior quality and/or regulatory leadership role (Director, VP, or C-level). Demonstrable experience managing a global team and multi-site quality operations is essential.
Regulatory Expertise
Deep, expert-level knowledge of global medical device regulations, including FDA QSR, ISO 13485, EU MDR 2017/745, and ISO 14971. Proven experience successfully hosting FDA inspections and other regulatory body audits. Extensive experience with regulatory submissions (510(k), PMA) for complex devices is required.
Technical Acumen
Strong experience with a wide range of medical devices, preferably including Class II and Class III devices. Experience with devices incorporating software (SaMD), electronics, and sterile products is highly advantageous.
Leadership & Influence
Exceptional leadership skills with a proven ability to build, motivate, and lead high-performance teams. A strategic thinker with the ability to translate complex regulations and quality principles into actionable business initiatives. Outstanding communication, presentation, and interpersonal skills, with the ability to influence and build consensus among a wide range of stakeholders, from engineers to board members.
Business Acumen
Strong financial and business acumen, with experience managing departmental budgets and contributing to strategic business planning. A data-driven mindset with a focus on metrics and continuous improvement methodologies (e.g., Lean, Six Sigma).
Certifications
Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Manager/Organizational Excellence (CQM/OE), or RAPS Regulatory Affairs Certification (RAC) are strongly preferred.
Benefits & Perks Offered
Our client offers a highly competitive and comprehensive executive compensation and benefits package, designed to attract and retain top-tier talent. This includes:
- Executive-level base salary and annual performance-based bonus
- Significant long-term incentive plan (equity/stock options)
- Comprehensive health, dental, vision, and life insurance plans
- Generous Paid Time Off (PTO) and company holidays
- 401(k) retirement plan with a strong company match
- Relocation assistance package for qualified candidates
- Funding for professional development, conferences, and continuing education
- Executive wellness programs and perks
- The opportunity to make a significant impact on global health in a dynamic, growth-oriented company
How to Apply
This is a confidential, retained search conducted by JRG Partners. If you are a visionary quality leader who meets the stringent requirements of this role and is ready to take on a career-defining challenge, we encourage you to apply. Please submit your resume and a cover letter detailing your qualifications and strategic vision for this role. Qualified candidates will be contacted by a representative from JRG Partners for an initial discussion.
To learn more about our expertise in this sector, please visit the JRG Partners’ Life Sciences Executive Search Practice page. We look forward to reviewing your application and exploring your potential to lead our client’s global quality organization.
