Role Overview for Chief Quality Officer – Minneapolis, MN
JRG Partners has been exclusively retained to identify a visionary and strategic Chief Quality Officer (CQO) for a pioneering medical device company headquartered in the vibrant med-tech hub of Minneapolis, MN. Our client is a market leader in the development and manufacturing of life-sustaining and life-enhancing medical technologies, with a global reputation for innovation, clinical excellence, and an unwavering commitment to patient safety. This is a rare opportunity to join a dynamic executive leadership team and shape the future of quality and compliance for an organization on a steep growth trajectory.
As the Chief Quality Officer, you will be the ultimate authority and advocate for quality across the entire enterprise. Reporting directly to the Chief Executive Officer, you will provide the strategic vision, leadership, and operational execution necessary to build and maintain a world-class, best-in-class Quality Management System (QMS). This role is not simply about compliance; it is about embedding a proactive, data-driven culture of quality that becomes a competitive advantage. You will be instrumental in guiding the company through complex global regulatory landscapes, ensuring that every product, from conception to post-market surveillance, meets the highest standards of safety, efficacy, and reliability.
The ideal candidate will be a seasoned executive with a profound understanding of the medical device industry and a proven track record of leading global quality and regulatory functions. You will be a strategic partner to the C-suite, providing critical insights that influence product development, manufacturing processes, and global expansion strategies. Your leadership will directly impact patient lives and solidify our client’s position as a trusted innovator in the healthcare community. This position requires a physical presence in Minneapolis, the heart of ‘Medical Alley’, offering a unique ecosystem of talent, innovation, and industry collaboration.
Key Responsibilities of Chief Quality Officer – Minneapolis, MN
The Chief Quality Officer will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Quality Leadership
Develop, articulate, and execute a comprehensive global quality and regulatory affairs strategy that is fully aligned with the company’s overarching business objectives. Champion a culture where quality is a shared responsibility and a source of organizational pride.
Global QMS Oversight
Assume ultimate ownership of the corporate Quality Management System. Ensure the QMS is robust, scalable, and impeccably maintained in compliance with all applicable global standards, including ISO 13485, and regulations from the FDA, EU (MDR/IVDR), Health Canada, and other international authorities.
Regulatory Compliance and Interface
Serve as the primary point of contact and official correspondent with all regulatory agencies worldwide, including the FDA, Notified Bodies, and Ministries of Health. Expertly lead the company through all regulatory inspections and audits, ensuring successful outcomes. Oversee the preparation, submission, and maintenance of all regulatory filings, such as 510(k)s, PMAs, and Technical Files.
Team Development and Mentorship
Lead, inspire, and develop a high-performing, global team of quality assurance and regulatory affairs professionals. Foster an environment of continuous learning, collaboration, and professional growth. Structure the department for scalability and future success.
Comprehensive Risk Management
Drive the implementation and continuous improvement of risk management processes compliant with ISO 14971 throughout the entire product lifecycle, from initial design and development through manufacturing and post-market activities.
Post-Market Surveillance and Vigilance
Oversee all post-market quality functions, including complaint handling, vigilance reporting, Medical Device Reporting (MDRs), and product recall management. Ensure that data from the field is effectively analyzed and fed back into the design and manufacturing processes for continuous improvement.
CAPA and Continuous Improvement
Champion a robust Corrective and Preventive Action (CAPA) system that effectively identifies, investigates, and resolves quality issues. Utilize data analytics and quality metrics (KPIs) to identify trends and drive systemic, data-driven improvements across the organization using methodologies such as Lean and Six Sigma.
Supplier Quality Management
Enhance and oversee the supplier quality program, including supplier selection, qualification, auditing, and performance monitoring. Ensure the entire supply chain adheres to the company’s stringent quality standards.
Executive Partnership
Collaborate closely with peers in R&D, Operations, Clinical Affairs, and Commercial teams to ensure seamless integration of quality and compliance requirements into all stages of the product lifecycle. Provide expert guidance on quality and regulatory matters to the executive team and Board of Directors.
Financial Stewardship
Develop and manage the annual budget for the global quality and regulatory affairs department, ensuring efficient allocation of resources to meet strategic objectives.
Requirements for the Chief Quality Officer – Minneapolis, MN
We are seeking an exceptional leader with a deep and demonstrable track record of success in the medical device industry. The qualifications for this role are stringent and reflect its critical importance.
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
Unimpeachable, expert-level knowledge of global medical device regulations. This must include a deep understanding of the FDA’s Quality System Regulation, as detailed in FDA 21 CFR Part 820, as well as ISO 13485, the European Medical Device Regulation (EU MDR), and requirements for other key international markets.
Product Experience
Extensive hands-on experience with Class II and/or Class III medical devices is mandatory. Experience with complex devices, such as active implantables, software as a medical device (SaMD), or combination products, will be highly valued.
Proven Leadership
Demonstrated success in building, leading, and mentoring large, geographically dispersed teams. Must possess exceptional executive presence, communication, and influencing skills, with the ability to articulate complex concepts to a variety of audiences, from engineers to board members.
Audit and Inspection Mastery
A proven track record of successfully leading organizations through numerous FDA inspections, Notified Body audits, and other regulatory assessments with positive outcomes.
Strategic and Business Acumen
The ability to think strategically and translate quality and regulatory requirements into actionable business plans. Must be capable of operating at both a high strategic level and a detailed tactical level when required.
Professional Certifications
Professional certifications such as Regulatory Affairs Certification (RAC) or certifications from the American Society for Quality (ASQ), such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA), are highly desirable.
Benefits & Perks Offered
Our client offers a comprehensive and competitive executive compensation and benefits package designed to attract and retain top-tier talent. This includes:
Executive Compensation
A highly competitive base salary, a significant annual performance-based bonus, and a meaningful long-term incentive plan (equity/stock options).
Health and Wellness
Premier medical, dental, and vision insurance plans for you and your dependents. A robust wellness program, including gym membership reimbursement and mental health resources.
Retirement Savings
A generous 401(k) retirement plan with a strong company matching contribution.
Work-Life Balance
An executive-level paid time off (PTO) policy, complemented by numerous company-paid holidays.
Relocation Assistance
A comprehensive relocation package is available for the successful candidate and their family to move to the Minneapolis-St. Paul metropolitan area.
Professional Growth
A dedicated budget for executive coaching, attendance at key industry conferences, and other professional development opportunities to ensure you remain at the forefront of the field.
Impactful Culture
The opportunity to work within a mission-driven organization where your contributions have a direct and tangible impact on patient health and well-being around the world.
How to Apply
JRG Partners is the exclusive search firm managing this critical recruitment effort. We are committed to a confidential, thorough, and respectful process for all candidates. If you are a transformative quality leader with the experience and passion to drive excellence in a world-class medical device organization, we invite you to express your interest.
To learn more about our specialized focus in this sector, please explore our medical device and life sciences executive search practice. To be considered for this opportunity, please submit your resume and a compelling cover letter through the application portal on this page. All inquiries and applications will be handled with the strictest confidence.
JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees.
