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# Chief Quality Officer (Medical Device) in Chicago, IL


Are you a quality-focused executive with a deep understanding of regulatory compliance, risk management, and product excellence in the medical device industry? We are seeking a Chief Quality Officer (Medical Device) in Chicago, IL, to lead and drive quality assurance, regulatory compliance, and continuous improvement strategies within a leading medical technology company. This role is ideal for a visionary leader with a strong track record in quality systems management, FDA/ISO regulations, and operational excellence.
As the Chief Quality Officer (Medical Device) in Chicago, IL, you will be responsible for overseeing all aspects of quality assurance, regulatory compliance, and risk mitigation, ensuring the highest standards in product safety and effectiveness. You will collaborate with cross-functional teams, implement best practices, and drive quality culture transformation. If you have expertise in quality management systems, compliance strategies, and continuous process improvements, this is a prime opportunity to impact a leading medical device organization.
About This Role
The Chief Quality Officer (Medical Device) in Chicago, IL, plays a critical role in ensuring product safety, regulatory compliance, and operational efficiency within the organization. This executive leader will spearhead quality management systems (QMS), risk assessment protocols, and global compliance strategies to maintain industry-leading standards. The position requires a proactive problem-solver who can develop scalable quality control processes while aligning with business objectives.
This role involves leading quality assurance initiatives, implementing regulatory frameworks, and collaborating with manufacturing and R&D teams to maintain the highest product integrity. The Chief Quality Officer (Medical Device) in Chicago, IL, will work closely with internal and external stakeholders, including regulatory bodies, to ensure continuous adherence to FDA, ISO, and global medical device regulations. If you are looking for an opportunity to lead a world-class quality program and drive regulatory excellence in a fast-paced medical device company, this role is for you.
Key Responsibilities – Chief Quality Officer (Medical Device) in Chicago, IL
1. Develop and Oversee Quality Management Systems (QMS)

Implement and enhance QMS in compliance with FDA, ISO 13485, and other global medical device regulations.
Ensure that quality processes align with industry best practices and evolving regulatory requirements.
Lead internal and external audits to assess QMS effectiveness and drive continuous improvements.

2. Lead Regulatory Compliance and Risk Management

Develop and maintain strategies to ensure compliance with FDA, EU MDR, ISO, and other regulatory frameworks.
Conduct regulatory risk assessments and implement measures to mitigate compliance risks.
Serve as the primary liaison with regulatory agencies and certification bodies.

3. Drive Product Quality and Safety Initiatives

Establish product quality benchmarks to enhance safety, efficacy, and reliability.
Monitor post-market surveillance data to assess product performance and customer feedback.
Collaborate with engineering and R&D teams to resolve quality concerns and implement preventive measures.

4. Oversee Supplier Quality and Manufacturing Compliance

Develop supplier qualification and monitoring programs to ensure high-quality materials and components.
Conduct supplier audits and implement corrective actions for non-conforming products.
Align manufacturing processes with Good Manufacturing Practices (GMP) and ISO standards.

5. Implement Continuous Improvement and Lean Six Sigma Strategies

Utilize Lean, Six Sigma, and Kaizen methodologies to improve operational efficiencies.
Foster a culture of continuous improvement, reducing defects and enhancing product lifecycle management.
Lead cross-functional teams to identify and implement process optimization initiatives.

6. Oversee Quality Control Testing and Validation

Ensure all medical devices undergo rigorous quality control testing before market release.
Supervise process validation, stability testing, and product lifecycle assessments.
Standardize test procedures to maintain consistent product performance.

7. Lead and Develop High-Performing Quality Teams

Build and mentor a world-class quality assurance and regulatory affairs team.
Provide leadership, training, and career development opportunities to quality professionals.
Foster a collaborative and compliance-driven culture within the organization.

8. Manage Recalls, CAPA, and Non-Conformance Reporting

Oversee Corrective and Preventive Actions (CAPA) processes to resolve quality issues.
Ensure timely reporting and management of non-conformances and potential product recalls.
Work closely with legal and regulatory teams to address compliance deviations and implement corrective strategies.

What The Client is Looking For in You
To excel as the Chief Quality Officer (Medical Device) in Chicago, IL, you should bring a combination of regulatory expertise, leadership acumen, and a strategic mindset to ensure product quality and compliance in a rapidly evolving medical device industry. The ideal candidate will possess:

Extensive Experience in Medical Device Quality Assurance – A strong background in FDA, ISO 13485, EU MDR, and global regulatory compliance is critical. Experience in auditing, risk management, and CAPA processes will set you apart.
Proven Leadership in Quality & Compliance – Demonstrated success in leading quality assurance, regulatory compliance, and risk management teams in a medical device setting. Experience in managing multi-site quality operations is a plus.
Expertise in Quality Management Systems (QMS) – Deep understanding of QMS implementation, quality control processes, and continuous improvement initiatives using methodologies such as Six Sigma, Lean Manufacturing, and Kaizen.
Strategic and Analytical Thinking – Ability to develop and execute long-term quality strategies, identify risks, and implement robust solutions to maintain compliance and product excellence.
Strong Leadership & Team Development Skills – Experience building, mentoring, and leading high-performing quality assurance and regulatory teams. A hands-on approach to fostering collaboration and driving a culture of quality is highly valued.
Supplier & Manufacturing Quality Expertise – A background in supplier quality management, manufacturing compliance, and process validation ensures alignment with industry best practices.
Ability to Manage Regulatory Relationships – Strong experience liaising with FDA, ISO auditors, and other regulatory bodies to navigate audits, inspections, and certifications effectively.
Problem-Solving and Crisis Management Skills – A proactive approach to addressing non-conformances, managing recalls, and implementing corrective and preventive actions (CAPA) to mitigate quality risks.

Why This Opportunity Stands Out
This role presents a unique opportunity to make a significant impact on medical device quality and compliance while working with an industry-leading company. As the Chief Quality Officer (Medical Device) in Chicago, IL, you will:

Lead a Mission-Driven Organization – Play a key role in ensuring that life-changing medical devices meet the highest standards of safety and efficacy.
Shape the Future of Quality & Regulatory Excellence – Implement innovative quality control strategies, risk management protocols, and continuous improvement initiatives that drive long-term success.
Competitive Compensation & Executive Benefits – Enjoy a lucrative salary, performance-based incentives, and a comprehensive benefits package designed for executive-level leadership.
Work with a Dynamic & Collaborative Team – Join a company culture that values innovation, regulatory excellence, and cross-functional collaboration.
Drive Global Market Expansion – Oversee quality strategies for international regulatory compliance, supporting the company’s growth into new markets worldwide.
Access to Cutting-Edge Technology – Work with state-of-the-art medical device technologies and implement the latest advancements in quality management, compliance automation, and risk assessment.
High-Level Leadership & Influence – Report directly to the CEO and executive team, contributing to the organization’s strategic vision and long-term quality goals.

FAQs About the Role
Q: What industries should I have experience in?A: You should have extensive experience in the medical device industry, specifically in quality assurance, regulatory compliance, and risk management. Experience in biotechnology, pharmaceuticals, or healthcare technology is a plus.
Q: Is relocation required for this position?A: The role is based in Chicago, IL. Candidates should either reside in the area or be open to relocation.
Q: What is the reporting structure for this role?A: The Chief Quality Officer (Medical Device) in Chicago, IL, will report directly to the CEO and collaborate with senior executives across R&D, manufacturing, regulatory affairs, and compliance teams.
Q: What leadership style is expected?A: We seek a proactive and results-driven leader who can build high-performing teams, foster a culture of quality, and implement regulatory best practices.
Q: What is the expected travel requirement?A: This role may require occasional travel for supplier audits, regulatory inspections, and industry conferences.
Q: What qualifications and skills are required?A: Candidates should have a bachelor’s or master’s degree in engineering, life sciences, regulatory affairs, or a related field, along with 10+ years of leadership experience in medical device quality assurance and regulatory compliance.
Q: How does this role contribute to the company’s overall success?A: The Chief Quality Officer (Medical Device) in Chicago, IL, is critical to ensuring compliance, mitigating risk, and maintaining the highest product quality standards, directly impacting the company’s reputation, market success, and regulatory standing.
Q: What is the hiring and onboarding timeline?A: The company aims to hire within the next 60–90 days. The onboarding process includes strategic planning sessions with leadership, deep dives into current quality processes, and alignment on future quality initiatives.
What Remuneration Can You Expect from This Job?
As the Chief Quality Officer (Medical Device) in Chicago, IL, you can expect a highly competitive compensation package that reflects your executive leadership role and impact on product quality, regulatory compliance, and risk management. The base salary for this role typically ranges between $225,000 – $300,000 per year, depending on experience, industry expertise, and achievements in driving quality assurance within the medical device sector.
Beyond the base salary, this position includes performance-based bonuses and incentives tied to key metrics such as regulatory compliance success, quality system improvements, and manufacturing excellence. Equity options or stock grants may also be offered to the right candidate, providing an opportunity to participate in the company’s long-term growth.
The benefits package includes comprehensive healthcare coverage (medical, dental, vision), a 401(k) retirement plan with company matching, executive-level perks, paid time off, and professional development opportunities. Additional benefits may include a relocation package, travel allowances, and industry conference participation.
This role offers not only a lucrative financial package but also the opportunity to drive quality excellence, enhance compliance strategies, and influence the future of medical device innovation while working alongside a dynamic leadership team.
How to Apply for This Chief Quality Officer (Medical Device) Position in Chicago, IL
If you are a seasoned quality leader with a proven track record in regulatory compliance, risk management, and product excellence within the medical device industry, we invite you to apply for the Chief Quality Officer (Medical Device) in Chicago, IL. This is a unique opportunity to shape quality strategies, drive operational improvements, and lead a best-in-class quality management team.
To apply, please submit your resume and a cover letter detailing your experience in quality assurance leadership, regulatory compliance, supplier quality management, and continuous process improvement in the medical device sector.
This role offers a rewarding opportunity to lead a high-performing quality team, ensure global regulatory compliance, and contribute to an organization committed to medical device innovation and patient safety. Apply today to take the next step in your executive career as a Chief Quality Officer (Medical Device) in Chicago, IL!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
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