Role Overview for Chief Quality Officer – San Francisco, CA
JRG Partners is proud to partner with a pioneering medical device company based in the vibrant innovation hub of San Francisco, CA, in their search for a visionary and strategic Chief Quality Officer (CQO). This is a paramount executive leadership position, reporting directly to the Chief Executive Officer and playing an integral role in the company’s strategic direction and long-term success. The successful candidate will be the ultimate authority on global quality and regulatory compliance, shaping a culture that prioritizes patient safety and product excellence above all else.
You will be entrusted with the critical responsibility of architecting and executing a world-class quality and compliance framework that not only meets but exceeds the stringent requirements of global regulatory bodies. This role demands a leader who can navigate the complex, ever-evolving landscape of medical device regulations while fostering innovation and driving operational efficiency. You will serve as the primary liaison with the FDA, Notified Bodies, and other international health authorities, ensuring the company maintains an impeccable compliance record.
Your leadership will directly impact the company’s ability to bring life-changing medical technologies to market, safeguarding its reputation and solidifying its position as an industry leader. This is an unparalleled opportunity to make a significant impact on global health outcomes from within a dynamic, fast-paced, and mission-driven organization.
Key Responsibilities of Chief Quality Officer – San Francisco, CA
The Chief Quality Officer will assume a wide range of strategic and operational responsibilities. This executive will be accountable for the entire quality and regulatory ecosystem, from initial product concept through post-market surveillance. Key duties include:
Executive Leadership & Strategy
Serve as a key member of the executive leadership team, providing expert counsel on all quality and regulatory matters. Develop, articulate, and implement a global quality vision and strategic plan that aligns with the company’s business objectives. Champion a proactive, pervasive culture of quality and compliance across all departments, including R&D, Manufacturing, and Commercial operations.
Quality Management System (QMS) Oversight
Assume ultimate ownership of the company’s Quality Management System. Ensure the QMS is robust, scalable, and in strict compliance with all applicable standards, including the FDA’s Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, EU MDR/IVDR, and other relevant global regulations. Drive continuous improvement of the QMS to enhance efficiency and effectiveness.
Regulatory Affairs & Global Compliance
Lead and direct all regulatory affairs activities. Develop global regulatory strategies for new and modified products. Oversee the preparation, submission, and maintenance of regulatory filings, such as 510(k)s, PMAs, and Technical Files/Design Dossiers. Act as the primary correspondent with regulatory agencies worldwide, expertly managing all communications, inspections, and audits.
Product Lifecycle Quality Assurance
Provide comprehensive quality oversight throughout the entire product lifecycle. Ensure robust implementation of Design Controls during the R&D phase, lead rigorous Risk Management activities compliant with ISO 14971, and oversee all aspects of validation (process, software, test method). Manage and continuously improve the Corrective and Preventive Action (CAPA), non-conformance, and complaint handling systems.
Post-Market Surveillance & Vigilance
Develop and manage a comprehensive post-market surveillance program to proactively monitor product performance and safety in the field. Ensure timely and accurate reporting of adverse events and vigilance activities to all relevant regulatory authorities, maintaining full compliance with global reporting requirements.
Operational & Supplier Quality
Partner with Manufacturing and Supply Chain leadership to drive operational excellence and a ‘quality-first’ mindset. Oversee the supplier quality management program, including qualification, auditing, and performance monitoring of critical suppliers and contract manufacturers to ensure the integrity of the supply chain.
Team Leadership & Development
Build, mentor, and lead a high-performing, global team of quality and regulatory affairs professionals. Foster a collaborative and accountable environment, promoting professional growth and ensuring the team has the skills and resources needed to excel.
Financial & Resource Management
Develop and manage the annual budget for the Quality and Regulatory Affairs department. Allocate resources effectively to support strategic initiatives and ensure compliance objectives are met in a fiscally responsible manner.
Requirements for the Chief Quality Officer – San Francisco, CA
The ideal candidate is a seasoned executive with a proven track record of success in the medical device industry. We are seeking a leader with a unique blend of technical expertise, strategic acumen, and inspirational leadership.
Educational Background
A Bachelor of Science (B.S.) degree in Engineering, Life Sciences, or a related technical field is required. An advanced degree (M.S., Ph.D., or M.B.A.) is strongly preferred.
Executive Experience
A minimum of 15-20 years of progressive experience in quality assurance and regulatory affairs within the medical device sector. At least 10 of these years must have been in a senior leadership capacity (e.g., Vice President, Senior Director) with a proven history of managing global teams and responsibilities.
Regulatory Expertise
Deep, expert-level knowledge of U.S. and international medical device regulations, including extensive experience with FDA 21 CFR Part 820, ISO 13485, the European Medical Device Regulation (EU MDR), and requirements from other key markets (e.g., Canada, Japan, Australia).
Product Experience
Demonstrated experience with a range of medical devices, including complex Class II and Class III devices. Experience with software as a medical device (SaMD) and combination products is highly desirable.
Proven Leadership
A history of successfully leading organizations through regulatory inspections (FDA, Notified Body, etc.) with positive outcomes. Demonstrable experience in building, scaling, and mentoring high-performance quality and regulatory teams.
Strategic Mindset
The ability to think strategically and translate business goals into a tangible quality and compliance roadmap. Strong analytical, problem-solving, and decision-making skills are essential.
Communication Skills
Exceptional executive presence with superior written and verbal communication skills. The ability to effectively communicate complex regulatory and quality concepts to a variety of audiences, from engineers to the Board of Directors.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a comprehensive and competitive compensation and benefits package, including:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance-based bonus and a substantial equity package (stock options/RSUs).
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents.
Retirement Savings
A robust 401(k) plan with a generous company matching contribution.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and paid company holidays.
Relocation Support
A comprehensive relocation package is available for the ideal candidate.
Professional Growth
A commitment to your ongoing professional development with support for conferences, certifications, and executive education.
Additional Perks
A suite of wellness programs, commuter benefits, and other perks designed to support a healthy and productive work environment in the heart of San Francisco.
How to Apply
JRG Partners is the exclusive recruitment partner for this confidential search. If you are a transformative quality and regulatory leader with the experience and passion to drive excellence in a cutting-edge medical device company, we invite you to apply. To be considered for this critical role, please submit your resume and a cover letter detailing your qualifications and leadership philosophy. All applications will be treated with the strictest confidence. To learn more about our expertise in this sector, please visit our Life Sciences & Healthcare practice area page. We look forward to reviewing your application and discussing this exciting opportunity with you.
