Chief Quality Officer – IVD Manufacturing Compliance | Raleigh, NC

Are you an accomplished quality leader with deep expertise in In Vitro Diagnostics (IVD) manufacturing compliance? We are seeking a Chief Quality Officer (CQO) to spearhead quality strategy and regulatory adherence for a leading IVD manufacturing organization based in Raleigh, NC. This is a unique opportunity to shape quality systems, ensure regulatory excellence, and lead continuous improvement initiatives in a highly regulated industry. If you excel at building robust compliance programs and fostering a culture of quality, this role is your next career milestone.

Lead Quality and Compliance for a Premier IVD Manufacturer in Raleigh

Our client, a recognized leader in the IVD manufacturing sector, is looking for a visionary Chief Quality Officer to oversee manufacturing compliance, quality assurance, and regulatory affairs. The ideal candidate brings extensive experience navigating FDA, ISO, and global regulatory standards within IVD or medical device manufacturing. If you are passionate about driving quality innovation, ensuring patient safety, and leading cross-functional teams to achieve operational excellence, this is your chance to make a significant impact in a growing organization.

Key Responsibilities of the Chief Quality Officer – IVD Manufacturing Compliance

Quality & Compliance Leadership: Develop, implement, and maintain a comprehensive quality management system that ensures compliance with FDA regulations, ISO standards (such as ISO 13485), and other global regulatory requirements specific to IVD manufacturing. Lead all quality assurance and quality control activities to uphold product safety and efficacy.

Regulatory Strategy & Oversight: Collaborate with regulatory affairs and manufacturing teams to interpret and implement evolving regulations impacting IVD products. Ensure all processes, documentation, and validations meet applicable regulatory standards and audit readiness.

Risk Management & CAPA: Drive a proactive risk management program to identify, assess, and mitigate quality and compliance risks throughout the product lifecycle. Oversee Corrective and Preventive Actions (CAPA) and complaint handling to resolve quality issues efficiently and effectively.

Continuous Improvement & Operational Excellence: Lead initiatives to optimize manufacturing quality processes, enhance product reliability, and reduce defects. Foster a culture of continuous improvement by leveraging data analytics, process audits, and cross-functional collaboration.

Supplier & Vendor Quality Management: Establish and maintain quality requirements for suppliers and contract manufacturers. Conduct supplier audits, monitor supplier performance, and ensure compliance with quality standards and specifications.

Team Leadership & Development: Build, mentor, and lead a high-performing quality assurance and compliance team. Promote training, professional development, and a culture of quality ownership across the organization.

Cross-Functional Collaboration: Partner with R&D, Manufacturing, Regulatory Affairs, and Supply Chain teams to integrate quality considerations early in product development and manufacturing processes, ensuring seamless product launches and sustained compliance.

Audit & Inspection Readiness: Prepare and lead internal and external audits, including regulatory inspections. Ensure timely response to audit findings and implement corrective actions to maintain regulatory compliance and certification status.

Documentation & Reporting: Oversee the accurate and timely documentation of quality records, management reviews, and quality metrics reporting. Provide leadership and stakeholders with transparent updates on quality performance and compliance status.

What the Client is Looking for in You

As the Chief Quality Officer (CQO) for IVD Manufacturing Compliance, the client seeks a highly experienced and strategic quality leader with a strong background in regulated environments. You should be a proactive, detail-oriented executive who excels at driving compliance, fostering a culture of quality, and leading cross-functional teams to achieve operational and regulatory excellence in the In Vitro Diagnostics industry.

Proven Expertise in IVD Quality and Regulatory Compliance

The ideal candidate will have deep knowledge and hands-on experience with FDA regulations, ISO 13485 standards, and other global regulatory requirements specific to IVD manufacturing. You should bring a proven track record of successfully implementing and managing quality systems that ensure product safety, reliability, and compliance in a highly regulated environment.

Strategic Quality Leadership with a Focus on Continuous Improvement

You must demonstrate the ability to develop and execute quality strategies that align with business goals and regulatory expectations. The client values leaders who can identify quality risks early, implement robust corrective and preventive actions (CAPA), and drive continuous improvement initiatives to optimize manufacturing processes and product quality.

Strong Risk Management and Problem-Solving Skills

Your expertise in risk assessment, mitigation, and quality issue resolution will be critical. The client seeks a CQO who can lead root cause analyses, manage complaint investigations, and foster a proactive approach to minimizing compliance risks and ensuring patient safety.

Ability to Build and Inspire High-Performing Quality Teams

Leadership skills are essential, with the ability to attract, develop, and retain talented quality professionals. You should cultivate a culture of accountability, collaboration, and quality ownership throughout the organization, enabling teams to excel in delivering compliant and high-quality products.

Excellent Cross-Functional Collaboration and Communication

The client values a CQO who can work seamlessly across R&D, manufacturing, regulatory affairs, and supply chain teams. Effective communication skills are essential to translate complex regulatory requirements into actionable quality plans and to ensure alignment on quality objectives at all organizational levels.

Commitment to Audit and Inspection Readiness

You should have extensive experience preparing for and leading internal and external audits, including regulatory inspections. Your ability to respond promptly and effectively to audit findings and maintain ongoing compliance is critical to sustaining certifications and regulatory approvals.

FAQs About the Role – Chief Quality Officer – IVD Manufacturing Compliance

1. What are the key responsibilities of the Chief Quality Officer in this role?

As the Chief Quality Officer (CQO), you will lead the development and execution of the company’s quality management system to ensure full compliance with FDA, ISO, and other global regulatory standards for IVD manufacturing. You will oversee quality assurance, risk management, regulatory readiness, supplier quality, and continuous improvement initiatives, ensuring the highest standards of product safety and efficacy.

2. What qualifications and experience are required for this position?

The ideal candidate will have extensive experience in quality leadership within the IVD or medical device manufacturing industry, with deep knowledge of FDA regulations, ISO 13485, and global compliance requirements. Proven success in managing quality systems, audits, CAPA, and regulatory inspections is essential. A degree in life sciences, engineering, or a related field is preferred, with advanced certifications such as Six Sigma or ASQ credentials considered a plus.

3. What leadership qualities are essential for this role?

The client seeks a strategic and detail-oriented leader with strong problem-solving skills, excellent communication, and the ability to inspire and mentor quality teams. You should be proactive in identifying and mitigating quality risks, adept at cross-functional collaboration, and committed to fostering a culture of quality and compliance throughout the organization.

4. What challenges can I expect in this role?

Challenges include maintaining rigorous compliance in a highly regulated and rapidly evolving IVD landscape, managing complex supplier and manufacturing networks, and driving continuous improvement while meeting tight production deadlines. You will need to navigate regulatory changes and audit expectations while balancing innovation with strict quality standards.

5. What is the expected impact of the Chief Quality Officer on the company’s success?

You will be instrumental in ensuring product quality and regulatory compliance that safeguard patient safety and company reputation. Your leadership will support operational excellence, reduce risk, and enable sustainable growth by driving consistent product quality and regulatory readiness.

6. What is the company’s culture and work environment like?

The company promotes a quality-first, collaborative culture focused on innovation and continuous improvement. It values leaders who empower teams, embrace accountability, and align quality initiatives with business objectives. You will be part of a dynamic, mission-driven organization dedicated to advancing healthcare diagnostics.

What Remuneration Can You Expect from This Job?

As the Chief Quality Officer (CQO) specializing in IVD Manufacturing Compliance in Raleigh, NC, you can anticipate a highly competitive compensation package designed to attract experienced quality executives in the medical device and diagnostics industry. The remuneration for this role typically includes:

1. Base Salary

The base salary for a CQO in the IVD or medical device sector depends on company size, complexity, and experience. Typically, annual base salaries range from $180,000 to $300,000, with larger or publicly traded companies offering higher base pay.

2. Performance-Based Bonuses

Most compensation packages include annual performance bonuses tied to quality metrics, regulatory compliance achievements, operational efficiency, and overall business objectives. These bonuses generally range from 20% to 50% of the base salary, reflecting individual and company performance.

3. Equity & Stock Options

Many IVD manufacturers offer equity incentives such as stock options or restricted stock units (RSUs) to align executive interests with long-term company success. Equity grants can be a valuable component of total compensation, particularly in growth-stage or publicly traded companies.

4. Long-Term Incentive Plans (LTIPs)

Some organizations provide LTIPs or profit-sharing plans that reward sustained performance and compliance excellence over multiple years. These programs encourage leadership focus on continuous quality improvements and long-term operational stability.

5. Executive Benefits & Perks

Comprehensive benefits often accompany this role, including:

Health, dental, and vision insurance
401(k) retirement plans with company match
Executive wellness and development programs
Travel allowances for regulatory or industry meetings
Expense accounts for business and compliance initiatives

6. Signing Bonuses & Relocation Assistance

For highly qualified candidates, companies may offer signing bonuses or relocation support to facilitate a smooth transition, typically ranging from $20,000 to $75,000 depending on the circumstances.

Total Compensation Potential

Taking all elements into account, total annual compensation for a Chief Quality Officer in IVD manufacturing typically ranges from $250,000 to $450,000 or more. The package is designed to reward proven leadership in quality and regulatory compliance, reflecting the critical role you will play in patient safety and company success.

How to Apply

If you are a seasoned quality executive with a strong background in In Vitro Diagnostics (IVD) manufacturing compliance and a passion for driving regulatory excellence, we invite you to apply for the Chief Quality Officer (CQO) role based in Raleigh, NC. This is a unique opportunity to lead quality strategy, ensure compliance with global regulatory standards, and foster a culture of continuous improvement within a dynamic healthcare diagnostics company.

To apply, please submit your resume and a cover letter highlighting your experience in IVD or medical device quality leadership, regulatory compliance (FDA, ISO 13485), risk management, and team development. Be sure to emphasize your success in building and maintaining quality management systems, leading audits and inspections, and driving quality innovations that align with business goals.

This role offers a high-impact leadership opportunity where you will be instrumental in safeguarding patient safety, enhancing product quality, and ensuring sustainable regulatory compliance. Apply today to advance your career as Chief Quality Officer – IVD Manufacturing Compliance in Raleigh, NC!

For additional information or to explore other leadership opportunities in medical device quality and compliance, please visit our In Vitro Diagnostics (IVD) Executive Search Specialists page.

Job Category: IVD Manufacturing Compliance

Job Type: Full Time

Job Location: Raleigh

Chief Quality Officer – IVD Manufacturing Compliance | Raleigh, NC