Role Overview for Chief Quality Officer – Boston, MA
JRG Partners is proud to partner with a pioneering medical device company at the forefront of healthcare innovation. Based in the vibrant life sciences hub of Boston, MA, our client is dedicated to developing and manufacturing life-changing technologies that improve patient outcomes worldwide. We are conducting an exclusive search for a visionary and strategic Chief Quality Officer (CQO) to join their executive leadership team. This is a career-defining opportunity to shape the future of quality and regulatory excellence within a dynamic, high-growth organization.
The Chief Quality Officer is more than a departmental head; you are the ultimate steward of product quality, patient safety, and regulatory integrity. You will provide the strategic vision, leadership, and hands-on guidance to ensure the company’s Quality Management System (QMS) is not only compliant but also a competitive advantage. Reporting directly to the Chief Executive Officer, you will be a key voice in all strategic decisions, influencing product development, manufacturing processes, and global market expansion. Your leadership will instill a proactive, pervasive culture of quality that permeates every level of the organization, from the research lab to the manufacturing floor and into the hands of clinicians and patients.
In this role, you will be responsible for the entire global quality and regulatory affairs function. You will lead a talented team of professionals, fostering their growth and empowering them to achieve excellence. You will be the primary point of contact for regulatory bodies such as the FDA, Notified Bodies, and other international health authorities, navigating complex regulatory landscapes with expertise and confidence. The ideal candidate is a seasoned leader with an impeccable track record in the medical device industry, capable of balancing rigorous compliance with the demands of a fast-paced, innovative environment. If you are driven by a passion for excellence and a commitment to patient safety, we invite you to explore this exceptional opportunity.
Key Responsibilities of Chief Quality Officer – Boston, MA
Strategic Leadership & Vision
Develop, articulate, and execute a comprehensive global quality and regulatory strategy that aligns with the company’s business objectives, growth plans, and long-term vision. Champion a culture of continuous improvement and quality-first mindset across all departments.
QMS Oversight & Management
Assume ultimate responsibility for the development, implementation, and maintenance of a robust and compliant Quality Management System (QMS) in accordance with global standards, including FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable international regulations.
Regulatory Compliance & Submissions
Direct all regulatory affairs activities, including the strategy, preparation, and submission of regulatory filings (e.g., 510(k), PMA, CE Mark Technical Files). Serve as the primary liaison with regulatory agencies during inspections, audits, and inquiries, ensuring transparent and effective communication.
Global Team Leadership
Lead, mentor, and develop a high-performing global team of quality assurance, quality control, and regulatory affairs professionals. Establish clear goals, provide regular feedback, and foster a collaborative and accountable work environment.
Risk Management
Oversee the enterprise-wide risk management program, ensuring compliance with ISO 14971. Proactively identify, assess, and mitigate quality and compliance risks throughout the entire product lifecycle, from design and development to post-market surveillance.
Audit Program Management
Direct internal and external audit programs to ensure ongoing compliance and identify opportunities for improvement. Host regulatory inspections and third-party audits, and manage all associated responses and corrective action plans.
Corrective and Preventive Action (CAPA)
Own the CAPA system, ensuring that root causes of non-conformances are thoroughly investigated and that effective, sustainable corrective and preventive actions are implemented and verified.
Supplier Quality Assurance
Develop and manage a robust supplier quality program, including supplier qualification, auditing, and performance monitoring, to ensure the integrity and quality of the entire supply chain.
Post-Market Surveillance & Vigilance
Oversee all post-market activities, including complaint handling, vigilance reporting, and trend analysis, to ensure timely response to product performance issues and continuous feedback into the product development cycle.
Executive Collaboration & Reporting
Collaborate closely with R&D, Operations, Clinical, and Commercial teams to integrate quality considerations into all business processes. Provide regular, insightful reports on quality metrics, compliance status, and strategic initiatives to the CEO and Board of Directors.
Requirements for the Chief Quality Officer – Boston, MA
Educational Background
A Bachelor’s degree in Engineering, Life Sciences, or a related technical field is required. An advanced degree (MS, PhD, or MBA) is strongly preferred.
Executive Experience
A minimum of 15 years of progressive experience in quality assurance and regulatory affairs within the medical device industry, with at least 7-10 years in a senior leadership capacity (Director, VP, or C-level).
Regulatory Expertise
Demonstrated mastery of global medical device regulations, including deep, hands-on experience with FDA QSR (21 CFR 820), ISO 13485, EU Medical Device Regulation (MDR 2017/745), and other international standards (e.g., Health Canada, TGA, PMDA).
Proven Leadership
A track record of successfully building, leading, and mentoring large, multi-site, and global quality organizations. Must possess exceptional interpersonal, communication, and influencing skills.
Device Experience
Extensive experience with Class II and/or Class III medical devices is essential. Experience with devices involving software (SaMD), electronics, and/or sterile disposables is highly advantageous.
Strategic Acumen
Ability to think strategically and translate business goals into actionable quality and regulatory plans. Experience in a fast-growing or publicly-traded company is a plus.
Audit & Inspection Management
Proven experience successfully hosting and managing FDA inspections, Notified Body audits, and other regulatory assessments.
Technical Skills
Strong understanding of design controls, process validation, risk management, statistical methods, and CAPA systems.
Certifications
Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC) are highly desirable.
Personal Attributes
High ethical standards, unwavering integrity, strong analytical and problem-solving skills, and the ability to thrive in a demanding, fast-paced environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent. The successful candidate will be rewarded with a highly competitive and comprehensive compensation package, including:
Executive Compensation
A competitive base salary, significant annual performance-based bonus, and a substantial long-term equity incentive package (stock options/RSUs).
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your dependents, along with wellness programs and a generous health savings account (HSA) contribution.
Retirement Planning
A 401(k) retirement plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, paid company holidays, and flexible work arrangements to support your personal and professional life.
Relocation Support
A comprehensive relocation package is available for the ideal candidate moving to the greater Boston area.
Professional Growth
A commitment to your continuous learning with support for professional development, industry conferences, and executive coaching.
Innovative Culture
The opportunity to work alongside brilliant, passionate colleagues in a mission-driven company that is making a tangible impact on global health.
How to Apply
JRG Partners is the exclusive recruitment firm for this Chief Quality Officer position. We are seeking a truly exceptional leader to fill this critical role. If you meet the qualifications outlined above and are ready to take on a new challenge with a world-class medical device company, we encourage you to apply.
To be considered, please submit your confidential resume and a compelling cover letter outlining your suitability for the role. All applications will be treated with the utmost confidentiality. For more information or to discuss your qualifications, please connect with our expert medical device recruitment team. We look forward to hearing from you and exploring this exciting opportunity together.
