Role Overview for Chief Quality Officer – San Diego, CA
JRG Partners is proud to announce an exclusive executive search for a transformative Chief Quality Officer (CQO) on behalf of our client, a pioneering medical device company headquartered in the vibrant life sciences hub of San Diego, California. This is a career-defining opportunity for a seasoned quality leader to join a dynamic executive team and steer the global quality and compliance strategy for a company renowned for its life-saving and life-enhancing technologies.
Our client is at the forefront of medical innovation, developing, manufacturing, and marketing a portfolio of Class II and Class III devices that address critical unmet clinical needs. They are driven by a culture of relentless innovation, scientific rigor, and an unwavering commitment to patient safety. As the Chief Quality Officer, you will be the ultimate guardian of this commitment, embedding a world-class quality mindset into every facet of the organization. You will not merely oversee compliance; you will champion quality as a strategic business driver, enhancing brand reputation, enabling market expansion, and ensuring sustainable growth.
This executive leadership role is responsible for the vision, strategy, and execution of all aspects of the global Quality Assurance and Regulatory Compliance functions. You will lead a dedicated team of professionals, fostering a culture of excellence, accountability, and continuous improvement. The ideal candidate will be a strategic thinker with a hands-on approach, capable of navigating the complexities of the global regulatory landscape while inspiring an organization to achieve the highest standards of product quality and safety. You will report directly to the Chief Executive Officer and serve as a key advisor to the board of directors on all quality-related matters.
Key Responsibilities of Chief Quality Officer – San Diego, CA
The Chief Quality Officer will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Quality Leadership
Develop, articulate, and implement a comprehensive global quality vision and strategy that aligns with the company’s overall business objectives. Champion a proactive, risk-based quality culture throughout the entire organization, from R&D to post-market surveillance.
Global Regulatory Compliance
Ensure the organization’s unwavering compliance with all applicable domestic and international regulations and standards. This includes maintaining expert-level knowledge of the FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485, EU Medical Device Regulation (MDR), and other relevant global requirements. Act as the primary liaison with regulatory agencies such as the FDA, Notified Bodies, and other international health authorities.
Quality Management System (QMS) Oversight
Direct and oversee all elements of the QMS to ensure its effectiveness and efficiency. This includes managing Design Controls, Production and Process Controls (P&PC), Corrective and Preventive Actions (CAPA), Complaint Handling, Risk Management (ISO 14971), Supplier Quality Management, and Change Control.
Team Development and Leadership
Lead, mentor, and develop a high-performing, multi-disciplinary global quality organization. Attract and retain top talent, fostering an environment of collaboration, professional growth, and empowerment. Structure the department for scalability and future growth.
Audits and Inspections Management
Expertly lead the company through all internal and external audits and inspections. Develop and execute robust audit readiness programs and ensure timely and effective closure of any findings.
New Product Development & Commercialization Support
Serve as a key strategic partner to the R&D and engineering teams, ensuring quality and compliance are integrated into the entire product lifecycle, from concept through commercialization. Provide critical guidance on design verification and validation, process validation, and regulatory submission strategies.
Post-Market Surveillance and Vigilance
Oversee robust post-market surveillance systems, including complaint analysis, medical device reporting (MDRs), vigilance reporting, and the analysis of post-market data to drive product improvements and ensure patient safety.
Continuous Improvement Initiatives
Drive a culture of continuous improvement across the organization. Implement and leverage data-driven methodologies such as Lean, Six Sigma, and statistical process control (SPC) to enhance product quality, reduce waste, and improve operational efficiency.
Executive Collaboration and Reporting
Collaborate effectively with other members of the executive leadership team (CEO, COO, CTO, etc.) to ensure alignment on strategic goals. Provide regular, insightful reports and metrics to the executive team and Board of Directors on the performance of the QMS and the overall state of quality.
Requirements for the Chief Quality Officer – San Diego, CA
We are seeking a candidate with a proven track record of executive leadership and deep expertise in the medical device industry. The ideal candidate will possess:
Educational Background
An advanced degree (M.S., Ph.D., or equivalent) in Engineering, Life Sciences, or a related technical field is strongly preferred. A Bachelor’s degree in a relevant field is required.
Executive Experience
A minimum of 15 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry, with at least 7-10 years in a senior leadership capacity (Director, VP, or C-level) with global responsibilities.
Technical Device Expertise
Extensive experience with Class II and/or Class III medical devices is mandatory. Experience with active implantable devices, sterile disposables, combination products, or Software as a Medical Device (SaMD) is highly desirable.
Regulatory Acumen
Demonstrated mastery of global medical device regulations, including FDA QSR, ISO 13485, EU MDR, and requirements for other key markets (e.g., Canada, Japan, Australia). Proven experience successfully hosting FDA inspections and Notified Body audits.
Proven Leadership
A history of building, leading, and inspiring high-performance, global teams. Must possess exceptional interpersonal, communication, and presentation skills, with the ability to influence and build consensus at all levels of the organization, including the Board of Directors.
Strategic and Business Mindset
The ability to think strategically and translate quality and compliance requirements into actionable business plans. Experience managing departmental budgets and resources effectively.
Problem-Solving Skills
Superior analytical and problem-solving skills, with a demonstrated ability to lead root cause analysis and implement effective, lasting solutions through a robust CAPA system.
Certifications
Professional certifications such as ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA) are highly regarded.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a comprehensive and competitive compensation package, including:
- Highly competitive executive base salary.
- Significant annual performance-based bonus potential.
- Meaningful equity participation through long-term incentive plans (stock options/RSUs).
- Comprehensive benefits package, including premium medical, dental, and vision coverage for you and your dependents.
- Generous 401(k) plan with company matching contributions.
- Substantial paid time off (PTO), paid holidays, and sick leave.
- Relocation assistance package available for exceptional candidates.
- A budget for professional development, executive coaching, and continuing education.
- The opportunity to make a tangible impact on patient lives within a dynamic, innovative, and collaborative company culture in the heart of San Diego.
How to Apply
JRG Partners is the exclusive recruitment partner for this confidential search. If you are a visionary quality leader ready to take on this challenging and rewarding role, we invite you to submit your resume and a cover letter detailing your qualifications and interest.
To apply, please send your application to our lead recruiter. For more information on our specialized recruitment services and to see how we connect top talent with leading companies, you can explore our expertise in medical device executive search. We look forward to reviewing your application and discussing this exceptional opportunity with you.
