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 Cambridge, MA. This is a rare opportunity to join a dynamic executive team and shape the future of quality and regulatory excellence in an organization dedicated to improving patient outcomes through groundbreaking technology. Our client is a market leader, renowned for its commitment to innovation, scientific rigor, and a culture that places patient safety at the forefront of every decision.
As the Chief Quality Officer, you will be the ultimate authority on all matters related to quality and regulatory compliance. This is not merely a functional role; it is a strategic leadership position that will influence every facet of the business, from initial product conception and R&D to manufacturing, commercialization, and post-market surveillance. You will be the champion of a proactive, world-class quality culture, ensuring that our client not only meets but exceeds the stringent requirements of global regulatory bodies.
Your vision will directly contribute to the company’s reputation for excellence, mitigate risk, and enable sustainable growth in a competitive global market. This role requires a leader who can balance strategic foresight with hands-on execution, inspire teams to achieve greatness, and serve as a trusted advisor to the CEO and the Board of Directors.
Role Overview for Chief Quality Officer – Cambridge, MA
The Chief Quality Officer will assume enterprise-level responsibility for the strategic direction, leadership, and execution of the global Quality and Regulatory Affairs functions. Reporting directly to the Chief Executive Officer, the CQO will be a critical member of the executive leadership team, providing the vision and expertise necessary to build and maintain a best-in-class Quality Management System (QMS). You will be entrusted with safeguarding the company’s integrity and its commitment to patient safety by ensuring all products are developed, manufactured, and distributed in compliance with all applicable international laws and standards.
This executive will lead a multi-disciplinary team of professionals responsible for Quality Assurance, Quality Control, Regulatory Affairs, and Compliance. The ideal candidate will be a strategic thinker with a deep understanding of the medical device landscape, capable of navigating complex regulatory challenges and fostering a culture of continuous improvement. You will be instrumental in scaling the quality systems to support a growing portfolio of innovative products, including complex Class II and life-sustaining Class III devices.
Your leadership will be pivotal in managing relationships with regulatory agencies like the FDA, Notified Bodies, and other international authorities, ensuring successful inspections, audits, and product submissions. Success in this role will be measured by the robustness of the quality system, the efficiency of regulatory processes, and the seamless integration of quality as a core business driver across the organization.
Key Responsibilities of Chief Quality Officer – Cambridge, MA
Strategic Leadership
Develop, articulate, and execute a comprehensive global quality and regulatory strategy that aligns with the company’s overall business objectives, technological roadmap, and long-term growth plans.
QMS Oversight
Provide ultimate oversight for the design, implementation, and maintenance of a robust and scalable Quality Management System (QMS) that is compliant with relevant standards, including the FDA’s Quality System Regulation (QSR) 21 CFR 820, ISO 13485, and other global requirements.
Regulatory Compliance
Ensure unwavering compliance with all applicable domestic and international medical device regulations, including FDA regulations, EU Medical Device Regulation (MDR), and other country-specific requirements. Serve as the primary point of contact and official correspondent for all regulatory bodies.
Team Development
Lead, mentor, and develop a high-performing, multi-site team of quality and regulatory professionals. Foster a collaborative and accountable culture that attracts and retains top talent in the industry.
Audit & Inspection Management
Expertly manage all internal and external audits and inspections by regulatory authorities (e.g., FDA, Notified Bodies). Develop and oversee strategies for timely and effective responses to observations and findings.
Risk Management
Champion and oversee all risk management activities in accordance with ISO 14971, ensuring that a systematic process for risk identification, analysis, and control is applied throughout the entire product lifecycle.
Corrective and Preventive Action (CAPA)
Own the CAPA system, ensuring that root causes of non-conformances are thoroughly investigated and that effective corrective and preventive actions are implemented and verified to prevent recurrence.
Cross-Functional Collaboration
Partner closely with R&D, Clinical, Operations, and Commercial teams to integrate quality and compliance requirements into the product development process (Design Controls), manufacturing, and supply chain management.
Post-Market Surveillance
Oversee all post-market activities, including complaint handling, medical device reporting (MDRs), recalls, and the collection and analysis of post-market surveillance data to drive product and process improvements.
Executive Reporting
Prepare and present regular, comprehensive reports on quality system performance, compliance status, and key metrics to the executive leadership team and Board of Directors during management reviews.
Supplier Quality
Develop and manage a robust supplier quality program, including supplier qualification, auditing, and performance monitoring to ensure the integrity of the supply chain.
Requirements for the Chief Quality Officer – Cambridge, MA
Educational Background
A minimum of a Bachelor’s degree in Engineering, Life Sciences, or a related technical field is required. An advanced degree (MS, PhD, or MBA) is highly preferred.
Executive Experience
A minimum of 15-20 years of progressive experience within the medical device industry, with at least 10 years in a senior leadership capacity (Director, VP, or C-level) overseeing Quality Assurance and/or Regulatory Affairs functions.
Regulatory Expertise
Demonstrated mastery of global medical device regulations, including deep, hands-on experience with FDA QSR (21 CFR 820), ISO 13485, EU MDR, and risk management (ISO 14971).
Product Experience
Proven track record of managing quality systems for complex medical devices, including significant experience with Class II and Class III devices. Experience with software as a medical device (SaMD) and combination products is a significant plus.
Agency Interaction
Extensive, first-hand experience leading interactions and negotiations with regulatory agencies, including the FDA (both pre-market and post-market) and international Notified Bodies. Must have a proven history of successfully hosting regulatory inspections.
Leadership Acumen
Exceptional leadership skills with the demonstrated ability to build, scale, and motivate a global, high-performance team. Must be able to influence and align stakeholders across all levels of the organization.
Strategic Mindset
Strong strategic and analytical skills with the ability to translate complex regulatory and quality concepts into actionable business strategies.
Communication Skills
Impeccable written and verbal communication skills, with the ability to articulate a clear vision and present complex information effectively to diverse audiences, including technical teams, executive leadership, and regulatory authorities.
Certifications
Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC) are highly desirable.
Location
Must be based in or willing to relocate to the greater Cambridge, MA area. This is an in-office executive leadership role.
Benefits & Perks Offered
Our client believes in investing in their people and offers a highly competitive and comprehensive executive benefits package, including:
Executive Compensation
An attractive base salary complemented by a significant annual performance-based bonus and a substantial long-term equity package (stock options/RSUs).
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents with low employee contributions.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous Paid Time Off (PTO) policy, including vacation, sick days, and company-paid holidays.
Relocation Support
A comprehensive relocation package is available for the ideal candidate and their family.
Professional Growth
A strong commitment to professional development, including support for attending industry conferences, workshops, and continuing education.
Impactful Work
The opportunity to hold a key leadership position in a mission-driven company whose products have a direct and positive impact on the lives of patients worldwide.
How to Apply
JRG Partners is the exclusive search firm retained for this critical Chief Quality Officer position. We are seeking a leader who is passionate about quality and ready to make a lasting impact. If you meet the qualifications outlined above and are ready to take on this challenging and rewarding opportunity, we encourage you to submit your application.
All inquiries and applications will be handled with the strictest confidence. To apply, please submit your resume and a cover letter detailing your relevant experience. For more information about our expertise in this sector, please visit our Medical Device practice area page. We look forward to reviewing your credentials and discussing this exceptional opportunity with you.
