Role Overview for Chief Quality Officer – Raleigh, NC
JRG Partners is proud to partner with a pioneering medical device company in their search for a visionary Chief Quality Officer (CQO). Based in the vibrant tech hub of Raleigh, North Carolina, our client is at the forefront of developing life-changing medical technologies that improve patient outcomes worldwide. This is a rare opportunity to join a dynamic executive team and shape the future of quality and compliance for an organization committed to innovation and excellence.
As the Chief Quality Officer, you will be the ultimate authority on all matters of quality, regulatory compliance, and patient safety. You will not just be a manager of systems; you will be a strategic leader, a cultural architect, and a key driver of business success. Your leadership will ensure that every product that leaves the facility not only meets but exceeds the most stringent global standards. You will be responsible for cultivating a proactive, world-class quality culture that permeates every department, from R&D and manufacturing to supply chain and post-market surveillance.
This role requires a strategic thinker with a hands-on approach, capable of navigating the complex regulatory landscape while fostering innovation and continuous improvement. You will be the champion of the customer and the patient, ensuring their safety and satisfaction are the cornerstones of the company’s mission. This executive position reports directly to the Chief Executive Officer and plays a pivotal role in the strategic planning and long-term growth of the company.
Key Responsibilities of Chief Quality Officer – Raleigh, NC
Strategic Quality Leadership
Develop and execute a global quality and compliance strategy that aligns with the company’s business objectives. Serve as a key member of the executive leadership team, providing critical input on business strategy, risk management, and operational excellence.
QMS Development & Oversight
Lead the design, implementation, and continuous improvement of a robust and efficient Quality Management System (QMS). Ensure the QMS is compliant with all applicable global regulations, including deep expertise in the FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485, MDSAP, and EU MDR.
Regulatory Compliance & Affairs
Serve as the primary liaison with regulatory bodies such as the FDA, Notified Bodies, and other international health authorities. Oversee all regulatory submissions, inspections, audits, and responses, ensuring timely and successful outcomes.
Risk Management
Champion a proactive, risk-based approach to quality throughout the entire product lifecycle, from initial design and development through manufacturing and post-market activities, in accordance with ISO 14971.
Team Leadership & Development
Build, mentor, and lead a high-performing global quality assurance and regulatory affairs organization. Foster a culture of accountability, collaboration, and continuous learning. Set clear objectives and provide the resources and support necessary for team success.
Post-Market Surveillance & Vigilance
Oversee all post-market activities, including complaint handling, CAPA (Corrective and Preventive Action) processes, recalls, and adverse event reporting. Ensure that data and customer feedback are effectively used to drive product and process improvements.
Supplier Quality Management
Develop and maintain a rigorous supplier quality program. Oversee supplier selection, qualification, audits, and performance monitoring to ensure the integrity and quality of the entire supply chain.
Operational Excellence
Partner with Manufacturing, R&D, and other cross-functional teams to drive continuous improvement initiatives using methodologies such as Lean and Six Sigma. Champion data-driven decision-making to enhance product quality, reduce costs, and improve efficiency.
Budget & Resource Management
Develop and manage the annual budget for the Quality and Regulatory departments, ensuring optimal allocation of resources to achieve strategic goals.
Requirements for the Chief Quality Officer – Raleigh, NC
Educational Background
A Bachelor’s degree in Engineering, Life Sciences, or a related technical field is required. A Master’s degree or PhD 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 role (Director, VP, or C-level).
Regulatory Expertise
Demonstrated mastery of global medical device regulations, including FDA QSR (21 CFR 820), ISO 13485, EU MDR, and MDSAP. Proven track record of successfully managing regulatory inspections and audits.
Technical Acumen
Experience with a wide range of medical devices, preferably including Class II and/or Class III devices. Strong understanding of design controls, risk management (ISO 14971), process validation, and sterilization processes.
Strategic Leadership Skills
Proven ability to develop and execute a strategic vision. Experience as a member of a senior executive team, contributing to overall business strategy. Exceptional leadership and people management skills with a history of building and developing high-performing teams.
Communication & Interpersonal Skills
Superior verbal and written communication skills. The ability to articulate complex technical and regulatory concepts to a variety of audiences, from engineers to the Board of Directors. Strong negotiation and influencing skills.
Problem-Solving Abilities
A data-driven, analytical, and systematic approach to problem-solving. A proven track record of effectively managing complex CAPA systems and driving root cause analysis.
Certifications
Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC) are highly desirable.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation package. As a key member of the executive team, you can expect:
Competitive Executive Salary
A highly competitive base salary commensurate with experience and market standards.
Executive Bonus Program
A significant annual performance-based bonus tied to both individual and company success.
Equity & Long-Term Incentives
A substantial equity package, providing a meaningful stake in the company’s long-term growth and success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents with low employee contributions.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and company holidays.
Professional Development
A dedicated budget for continuous learning, including executive coaching, industry conferences, and advanced certifications.
Relocation Assistance
A comprehensive relocation package is available for qualified candidates moving to the Raleigh area.
Additional Perks
Including life insurance, disability coverage, and a wellness program.
How to Apply
JRG Partners has been exclusively retained for this critical search. We are seeking a transformative leader who is passionate about quality and patient safety. If you are a seasoned quality executive with a proven track record of success in the medical device industry and are ready to make a significant impact, we encourage you to apply.
To be considered for this confidential opportunity, please submit your resume and a cover letter outlining your qualifications. For more information on our expertise in this sector, please visit our Medical Device Recruiting practice area. We look forward to reviewing your application.
