Role Overview for Chief Quality Officer – New York, NY
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 hub of New York, NY. This is a career-defining opportunity to join a forward-thinking executive team dedicated to developing life-changing technologies that enhance patient outcomes globally. Our client is renowned for its commitment to innovation, scientific rigor, and an unwavering focus on product quality and safety.
As the Chief Quality Officer, you will be the ultimate authority and strategic leader for all global quality assurance and regulatory affairs functions. Reporting directly to the Chief Executive Officer, you will serve as a critical member of the senior leadership team, providing the vision, strategy, and operational execution necessary to maintain the highest standards of quality and ensure seamless regulatory compliance across all global markets.
This role is not merely about compliance; it is about championing a pervasive culture of quality that permeates every facet of the organization, from initial concept and R&D to manufacturing, post-market surveillance, and customer feedback. You will be the principal architect of a robust, scalable, and world-class Quality Management System (QMS) that not only meets but exceeds the stringent requirements of regulatory bodies worldwide. Your leadership will directly impact patient safety, product efficacy, and the company’s long-term growth and reputation as a leader in the medical technology space.
Key Responsibilities of Chief Quality Officer – New York, NY
The Chief Quality Officer will have a broad and impactful scope of responsibilities, including but not limited to:
Executive Leadership & Strategy
Develop, articulate, and execute a comprehensive global quality and regulatory strategy that aligns with the company’s business objectives. Serve as the key quality and regulatory advisor to the CEO and the Board of Directors, providing critical insights and guidance on compliance risks, market entry strategies, and industry trends.
Global Quality Management System (QMS) Oversight
Assume ultimate ownership of the company’s QMS, ensuring its effectiveness and compliance with FDA QSR (21 CFR 820), ISO 13485, MDSAP, EU MDR, and other applicable international standards. Drive continuous improvement initiatives within the QMS using methodologies such as Lean, Six Sigma, and data-driven analysis to enhance efficiency and effectiveness.
Regulatory Affairs Leadership
Spearhead all regulatory submission activities, including 510(k)s, Pre-Market Approvals (PMAs), De Novo classifications, and CE Markings under the new EU MDR. Formulate and implement global regulatory strategies to ensure timely product approvals and maintain market access. Act as the primary, high-level liaison with the FDA, Notified Bodies, and other global health authorities.
Compliance and Audit Management
Ensure the entire organization operates in a state of constant audit-readiness. Lead the preparation for and management of all external regulatory inspections and internal audits. Oversee a robust Corrective and Preventive Action (CAPA) program, ensuring timely and effective resolution of quality issues.
Product Lifecycle Quality Assurance
Provide authoritative quality and regulatory oversight throughout the entire product lifecycle. This includes active involvement in Design Controls, Risk Management (ISO 14971), process validation (IQ/OQ/PQ), manufacturing operations, and labeling/promotional material review.
Post-Market Surveillance & Vigilance
Direct all post-market activities, including complaint handling, medical device reporting (MDRs), recalls, and field actions. Ensure that data from post-market surveillance is effectively analyzed and fed back into the QMS and product development processes.
Team Development & Mentorship
Build, lead, and mentor a world-class, multi-disciplinary team of quality and regulatory professionals. Foster a collaborative and accountable culture of quality excellence, empowering team members and promoting their professional growth.
Supplier Quality Management
Oversee the development and implementation of a comprehensive supplier quality program, including supplier qualification, auditing, and performance monitoring to ensure the integrity of the supply chain.
Financial & Resource Management
Develop and manage the annual budget for the quality and regulatory departments, ensuring optimal allocation of resources to achieve strategic goals and maintain compliance.
Requirements for the Chief Quality Officer – New York, NY
The ideal candidate will be a seasoned executive with a proven track record of success in the medical device industry. Specific qualifications include:
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., M.B.A., or Ph.D.) is strongly preferred.
Executive Experience
A minimum of 15 years of progressive experience in quality and regulatory affairs within the medical device sector, with at least 7-10 years in a senior leadership capacity (e.g., Vice President, Senior Director) with global responsibilities.
Regulatory Expertise
Demonstrated, expert-level knowledge of global medical device regulations, including deep familiarity with FDA 21 CFR Parts 820, 803, 806, and Part 11. Comprehensive understanding and practical application of ISO 13485, the EU Medical Device Regulation (MDR 2017/745), and the Medical Device Single Audit Program (MDSAP).
Submission Success
A proven history of successful pre-market submissions and registrations in major global markets (US, EU, etc.) for a range of device classes, preferably including Class II and Class III devices. Experience with software as a medical device (SaMD) and combination products is highly advantageous.
Leadership & Influence
Exceptional leadership skills with the demonstrated ability to build and lead high-performing teams. Must possess the executive presence and communication skills to effectively influence and collaborate with executive peers, board members, and external regulatory bodies.
Strategic Mindset
Strong strategic thinking, analytical, and problem-solving skills. The ability to translate complex regulatory and quality requirements into actionable business strategies.
Certifications
Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or RAPS Regulatory Affairs Certification (RAC) are highly desirable.
Location
The candidate must be able to work on-site at the company headquarters in New York, NY. A comprehensive relocation package is available for the right candidate.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a highly competitive and comprehensive compensation and benefits package, which includes:
Executive Compensation
A competitive base salary complemented by a significant annual performance-based bonus.
Long-Term Incentives
A substantial equity package (stock options or RSUs) to ensure alignment with the company’s long-term success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A 401(k) plan with a generous company matching contribution.
Paid Time Off
A generous and flexible paid time off (PTO) policy, in addition to company-paid holidays.
Relocation Support
A comprehensive relocation assistance package for candidates moving to the New York City area.
Professional Growth
A strong commitment to professional development, including support for attending industry conferences, workshops, and continuing education.
Executive Wellness
Access to executive wellness programs and other perks designed to support a healthy work-life balance.
How to Apply
JRG Partners is the exclusive search firm retained for this Chief Quality Officer engagement. We are seeking exceptional leaders who are ready to make a significant impact in a dynamic and innovative environment. If you possess the experience, expertise, and leadership qualities outlined above, we invite you to begin a confidential discussion with us.
To express your interest, please submit your resume and a cover letter detailing your qualifications. For more information about our expertise in this sector, please visit our dedicated Medical Device Recruiting practice area. All inquiries and applications will be handled with the utmost discretion and confidentiality. We look forward to connecting with you and exploring this exciting opportunity.
