Role Overview for Chief Quality Officer – Chicago, IL
JRG Partners is proud to partner with a pioneering force in the medical device industry to identify an exceptional executive for the role of Chief Quality Officer (CQO). Based in the vibrant city of Chicago, IL, this is a career-defining opportunity to join the C-suite of a company renowned for its commitment to innovation, patient safety, and product excellence. Our client is a global leader in developing, manufacturing, and marketing life-changing medical technologies that address complex healthcare challenges.
The Chief Quality Officer is a strategic visionary and a hands-on leader who will serve as the ultimate authority on all quality and regulatory matters across the global organization. This executive will be instrumental in shaping the company’s future by ensuring that every product not only meets but exceeds the most stringent international standards of safety, efficacy, and quality. Reporting directly to the Chief Executive Officer, the CQO will be a key member of the executive leadership team, providing critical guidance that influences corporate strategy, product development, manufacturing processes, and global market access.
This role demands a leader who can cultivate a world-class culture of quality that permeates every department and every level of the organization. You will be responsible for championing a proactive, risk-based approach to quality management, transforming the quality function from a compliance gatekeeper into a strategic business partner that drives competitive advantage. The ideal candidate will possess a deep understanding of the global regulatory landscape for medical devices, coupled with a proven track record of building and leading high-performing, multi-disciplinary teams. You will be the voice of quality at the executive table, ensuring that the patient is at the center of every decision we make.
Success in this position requires a unique blend of technical expertise, strategic acumen, and inspirational leadership. You will navigate the complexities of global regulations, lead the organization through rigorous audits and inspections, and drive continuous improvement initiatives that enhance efficiency, reduce costs, and accelerate time-to-market without compromising on quality. This is more than a job; it is a chance to leave a lasting legacy on an organization and an industry dedicated to improving human health.
Key Responsibilities of Chief Quality Officer – Chicago, IL
Strategic Leadership & Vision
- Develop and execute a comprehensive, forward-looking global quality and regulatory strategy that aligns with the company’s overall business objectives and growth plans.
- Serve as the primary quality and regulatory advisor to the CEO and the Board of Directors, providing insights and guidance on risks, opportunities, and industry trends.
- Champion and embed a robust ‘Culture of Quality’ throughout the organization, ensuring that quality ownership is understood and embraced by all employees.
- Establish key performance indicators (KPIs) and metrics to monitor the effectiveness of the quality system, reporting progress and strategic recommendations to the executive team.
- Lead strategic planning for the quality function, including budgeting, resource allocation, and talent development to build a world-class organization.
Quality Management System (QMS) Oversight
- Assume ultimate responsibility for the development, implementation, and maintenance of the corporate Quality Management System (QMS) to ensure its effectiveness and efficiency.
- Ensure the QMS is compliant with all applicable global regulations, including the FDA’s Quality System Regulation (QSR) under 21 CFR Part 820, ISO 13485, EU Medical Device Regulation (MDR), and other international standards.
- Direct and oversee all aspects of the QMS, including but not limited to Document Control, Change Control, CAPA (Corrective and Preventive Action), Complaint Handling, Internal Audits, and Management Reviews.
- Drive the integration of risk management principles (ISO 14971) into all aspects of the product lifecycle, from design and development to post-market surveillance.
- Leverage data analytics and digital tools to enhance QMS processes, improve visibility into quality trends, and facilitate data-driven decision-making.
Regulatory Compliance & Affairs
- Serve as the primary liaison with global regulatory bodies, including the FDA, Notified Bodies, Health Canada, and other international competent authorities.
- Lead the organization through all external audits and inspections, ensuring successful outcomes and timely resolution of any findings.
- Oversee the development and execution of regulatory submission strategies for new products and product modifications (e.g., 510(k), PMA, CE Marking).
- Monitor the evolving global regulatory landscape, proactively assessing the impact of new or revised regulations on the business and implementing necessary changes to maintain compliance.
- Direct post-market surveillance activities, including vigilance reporting, medical device reporting (MDRs), and product recall management, ensuring timely and effective communication with regulatory agencies.
Team Leadership & Development
- Lead, mentor, and develop a global team of quality assurance and regulatory affairs professionals, fostering an environment of collaboration, innovation, and continuous learning.
- Structure the quality organization for optimal effectiveness, ensuring clear roles, responsibilities, and accountability.
- Implement robust talent management and succession planning programs within the quality function to build a strong leadership pipeline.
- Inspire and motivate the team to achieve departmental and corporate goals, promoting a high-performance work ethic.
Requirements for the Chief Quality Officer – Chicago, IL
Educational & Professional Qualifications
- 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 MBA) is strongly preferred.
- Minimum of 15 years of progressive leadership experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
- At least 7 years of experience in a senior leadership role (Director level or above) with responsibility for managing a global team and setting strategic direction.
- Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC) are highly desirable.
Technical Skills & Experience
- Expert-level knowledge of global medical device regulations, including FDA 21 CFR Part 820, ISO 13485, EU MDR 2017/745, and requirements for other key markets (e.g., Canada, Japan, Australia).
- Demonstrated experience successfully hosting and managing regulatory inspections by the FDA and other international bodies.
- Proven track record of developing, implementing, and maintaining an effective, multi-site Quality Management System.
- Extensive experience with all phases of the product lifecycle, from R&D and design controls to manufacturing, sterilization, and post-market activities.
- Strong background in risk management (ISO 14971), CAPA systems, and data-driven continuous improvement methodologies (e.g., Six Sigma, Lean).
Leadership & Personal Attributes
- Exceptional strategic thinking and problem-solving skills with the ability to translate complex regulations and quality principles into actionable business strategies.
- Outstanding communication, presentation, and interpersonal skills, with the ability to influence and build consensus among senior executives, peers, and regulatory authorities.
- Proven ability to lead, inspire, and develop large, geographically dispersed teams.
- High level of integrity, ethics, and a strong commitment to patient safety.
- Decisive and results-oriented, with the ability to thrive in a fast-paced, dynamic environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent. The comprehensive compensation and benefits package for the Chief Quality Officer includes:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance-based bonus and a long-term equity incentive plan.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your dependents, along with a robust wellness program, and Health Savings Account (HSA) or Flexible Spending Account (FSA) options.
Retirement Planning
A 401(k) retirement savings plan with a generous company match to help you secure your financial future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick days, and company holidays, to support a healthy work-life integration.
Professional Growth
A substantial budget for professional development, including executive coaching, industry conferences, and continuing education.
Relocation Support
A comprehensive relocation package is available for the successful candidate and their family.
Additional Perks
Executive-level perquisites such as life insurance, disability coverage, and potential eligibility for a deferred compensation plan.
How to Apply
JRG Partners is exclusively managing the search for this pivotal Chief Quality Officer position. If you are a visionary quality leader with the experience and passion to drive excellence in a leading medical device company, we invite you to take the next step in your career.
To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications and strategic vision for a world-class quality organization. Interested candidates can learn more about our expertise in this sector by visiting our Medical Device Executive Search practice page.
JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
