Are you a quality-focused leader with a passion for ensuring product excellence in the medical device industry? We are seeking a Director of Quality Control (Med Device) in Cleveland, OH, to oversee and enhance the quality control operations of a rapidly growing medical device company. This executive role demands a detail-oriented professional with extensive experience in quality assurance, regulatory compliance, and continuous process improvement within the medical device sector.
As the Director of Quality Control (Med Device) in Cleveland, OH, you will be responsible for developing and implementing quality control strategies, ensuring compliance with FDA and ISO regulations, and leading a team of quality control professionals. If you have a strong track record of maintaining the highest product quality standards while optimizing processes, this opportunity is tailored for you.
About This Role
The Director of Quality Control (Med Device) in Cleveland, OH plays a crucial role in maintaining product integrity, meeting regulatory requirements, and fostering a culture of quality excellence. This position involves designing and refining quality control systems, overseeing audits and inspections, and implementing corrective action plans. The Director of Quality Control (Med Device) in Cleveland, OH, will collaborate with cross-functional teams to ensure compliance across all production stages while spearheading quality improvement initiatives.
This leadership role is ideal for a strategic thinker who thrives in fast-paced environments and has a passion for driving operational efficiency and product excellence. With opportunities to impact company-wide quality processes and ensure regulatory adherence, this position offers a dynamic career path in a company dedicated to advancing medical device innovation.
Key Responsibilities – Director of Quality Control (Med Device) in Cleveland, OH
Develop and Implement Quality Control Strategies
- Establish and execute robust quality control procedures to ensure product consistency and compliance.
- Develop quality assurance frameworks aligned with FDA, ISO 13485, and other regulatory standards.
- Continuously refine testing methodologies to enhance efficiency and accuracy.
Oversee Compliance with Regulatory Standards
- Ensure all quality control processes comply with FDA, ISO 13485, and other applicable regulations.
- Prepare for and lead audits and inspections conducted by regulatory agencies.
- Maintain documentation to support regulatory submissions and compliance efforts.
Lead Quality Control Team
- Manage and mentor a team of quality control professionals, ensuring high-performance standards.
- Provide training and continuous development to enhance team capabilities in quality assurance.
- Foster a culture of quality and accountability across all production and operational teams.
Monitor and Improve Quality Metrics
- Establish KPIs to measure and track quality performance across manufacturing and supply chains.
- Analyze quality data to identify trends, areas for improvement, and potential risks.
- Implement continuous improvement initiatives to reduce defects and enhance product reliability.
Oversee Product Testing and Validation
- Ensure rigorous testing of raw materials, in-process production, and finished medical devices.
- Develop protocols for stability testing, sterility assurance, and performance evaluations.
- Collaborate with engineering teams to assess product design for quality and safety.
Implement Corrective and Preventive Actions (CAPA)
- Lead root cause analysis efforts to identify and resolve quality issues.
- Develop and enforce corrective action plans to address deviations and non-conformances.
- Monitor CAPA effectiveness to prevent recurrence of quality-related issues.
Enhance Supplier Quality Management
- Establish and maintain quality standards for suppliers and third-party manufacturers.
- Conduct supplier audits and assessments to ensure compliance with company quality expectations.
- Implement supplier quality improvement programs to mitigate risks and enhance overall product quality.
Drive Continuous Quality Improvement Initiatives
- Identify opportunities for process enhancements to improve manufacturing efficiency and reduce waste.
- Utilize Six Sigma, Lean Manufacturing, and other quality improvement methodologies.
- Collaborate with leadership teams to drive company-wide quality initiatives.
What The Client is Looking For in You
To succeed as the Director of Quality Control (Med Device) in Cleveland, OH, you must possess a unique combination of leadership skills, regulatory expertise, and a strong commitment to quality excellence. The ideal candidate will bring:
- Extensive Experience in Medical Device Quality Control – A proven track record in quality assurance, quality control, and regulatory compliance within the medical device industry, ensuring adherence to FDA, ISO 13485, and other industry standards.
- Regulatory and Compliance Expertise – Deep knowledge of regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and risk management under ISO 14971. Experience leading audits and handling regulatory inspections is essential.
- Strategic Leadership and Team Management – Strong experience leading and mentoring quality control teams, fostering a culture of continuous improvement, accountability, and operational excellence.
- Data-Driven Problem-Solving Skills – The ability to analyze quality metrics, implement corrective actions, and drive improvements based on data-driven insights. Expertise in Six Sigma, Lean Manufacturing, or similar methodologies is preferred.
- Product Testing and Validation Expertise – Experience developing and executing test protocols, including raw material inspections, in-process quality checks, and final product validations.
- Supplier Quality Management Proficiency – Strong ability to assess and oversee supplier quality, ensuring compliance with company standards and industry regulations.
- Excellent Communication and Cross-Functional Collaboration – The ability to work closely with regulatory affairs, manufacturing, engineering, and leadership teams to align quality control strategies with business objectives.
- Passion for Innovation and Process Optimization – A forward-thinking mindset with a focus on continuous improvement, process efficiency, and maintaining the highest product quality standards.
Why This Opportunity Stands Out
This position offers a unique opportunity for an experienced quality control leader to make a significant impact in the medical device industry. As the Director of Quality Control (Med Device) in Cleveland, OH, you will:
- Join a Leading Medical Device Manufacturer – Be part of an organization known for its commitment to quality, innovation, and regulatory excellence.
- Play a Critical Role in Ensuring Patient Safety – Your leadership in quality control directly impacts product safety, reliability, and regulatory compliance.
- Lead High-Impact Quality Initiatives – Take ownership of quality strategies, process improvements, and compliance efforts that drive company-wide success.
- Competitive Compensation & Executive Benefits – Enjoy a strong compensation package, including performance-based bonuses, executive-level benefits, and long-term growth opportunities.
- Collaborate with a World-Class Leadership Team – Work alongside top executives and industry experts in a dynamic, fast-paced environment.
- Career Growth & Advancement Opportunities – Gain exposure to cutting-edge quality management systems and advance your career within a growing medical device company.
- A Culture of Innovation and Excellence – Be part of a team that values continuous improvement, professional development, and industry leadership.
FAQs About the Role
Q: What industries should I have experience in?
A: Candidates should have a strong background in medical device quality control, including experience with regulatory compliance, quality assurance, and manufacturing process improvements.
Q: Is relocation required for this position?
A: This role is based in Cleveland, OH. Candidates must be willing to relocate or currently reside in the area.
Q: What is the reporting structure for this role?
A: The Director of Quality Control (Med Device) in Cleveland, OH reports directly to the Vice President of Quality & Regulatory Affairs and collaborates with cross-functional teams.
Q: What kind of leadership style is expected?
A: We are looking for a hands-on, results-driven leader who can inspire teams, implement best practices, and drive a culture of continuous quality improvement.
Q: What are the travel requirements for this role?
A: This position may require occasional travel for supplier audits, regulatory meetings, and industry conferences.
Q: What are the key qualifications required for this position?
A: Candidates should have a bachelor’s or master’s degree in Quality Management, Engineering, or a related field, along with 10+ years of experience in medical device quality control and compliance.
Q: What are the company’s expectations regarding quality control improvements?
A: The company expects the Director of Quality Control (Med Device) in Cleveland, OH to enhance quality systems, improve supplier quality management, and maintain compliance with evolving industry regulations.
Q: What is the timeline for hiring and onboarding?
A: The company is looking to fill this position within the next 60–90 days. The onboarding process will include strategy meetings, quality system assessments, and collaboration with key stakeholders.
What Remuneration Can You Expect from This Job?
As the Director of Quality Control (Med Device) in Cleveland, OH, you can expect a highly competitive compensation package that reflects the importance of this role in ensuring regulatory compliance, product excellence, and operational efficiency. The base salary typically falls in the range of $150,000 – $180,000 per year, depending on your experience, qualifications, and expertise in medical device quality control and regulatory compliance.
In addition to the base salary, the position offers performance-based incentives tied to quality metrics, operational improvements, and regulatory successes. Equity options or stock grants may also be available for candidates with exceptional leadership skills and a proven track record in quality management.
The comprehensive benefits package includes:
- Health, Dental, and Vision Insurance – Full coverage for employees and dependents.
- 401(k) Retirement Plan with Employer Matching – A structured plan to help you secure your financial future.
- Annual Performance Bonuses – Based on achieving key quality and compliance objectives.
- Generous PTO and Paid Holidays – Work-life balance support with a competitive leave structure.
- Professional Development Opportunities – Access to training programs, industry conferences, and certification courses.
- Relocation Assistance (If Required) – Support for candidates moving to Cleveland, OH for this role.
This remuneration package ensures both financial and professional growth, making this an excellent opportunity for experienced quality control leaders in the medical device industry.
How to Apply for This Director of Quality Control (Med Device) Position in Cleveland, OH
If you are a seasoned quality control leader with extensive experience in medical device manufacturing, regulatory compliance, and quality assurance, we invite you to apply for the Director of Quality Control (Med Device) in Cleveland, OH. This is a strategic leadership role where you will be instrumental in ensuring product excellence, compliance with global regulations, and continuous quality improvements.
To apply, please submit your resume and a detailed cover letter outlining your expertise in ISO 13485 compliance, FDA regulations, and quality management systems.
This role presents an exceptional opportunity to lead a high-impact quality control team, drive continuous improvement initiatives, and contribute to the development of cutting-edge medical devices. Apply today to take the next step in your executive career as a Director of Quality Control (Med Device) in Cleveland, OH!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Quality Control | Medical Device Quality Assurance | Regulatory Compliance | Quality Control Leadership | ISO 13485 Compliance | FDA Regulations
