Director of Quality Systems (Medical Device) in Memphis, TN

Are you a quality-focused leader with a deep understanding of medical device regulations and compliance? We are seeking a Director of Quality Systems (Medical Device) in Memphis, TN, to lead quality assurance initiatives, ensure regulatory compliance, and drive continuous improvement in quality management systems. This executive role requires a seasoned professional with a strong background in FDA, ISO 13485, and other regulatory standards, as well as experience in leading cross-functional teams to enhance product quality and operational excellence.

As the Director of Quality Systems (Medical Device) in Memphis, TN, you will play a critical role in shaping and maintaining the company’s quality systems, ensuring adherence to all applicable regulations, and driving a culture of quality throughout the organization. If you have a proven track record of leading quality assurance programs, regulatory audits, risk management, and process improvements within the medical device industry, we encourage you to apply.

About This Role

The Director of Quality Systems (Medical Device) in Memphis, TN, is responsible for developing, implementing, and managing quality systems and compliance programs that meet industry regulations and support business objectives. This role requires an expert in quality management, regulatory compliance, and risk mitigation who can ensure that all products and processes align with FDA, ISO 13485, and global quality standards.

As the Director of Quality Systems (Medical Device) in Memphis, TN, you will lead cross-functional teams, oversee internal and external audits, manage non-conformance investigations, and implement quality improvements that enhance product safety and reliability. This position is a key leadership role that provides strategic direction to quality assurance teams, collaborates with regulatory bodies, and ensures a proactive approach to quality and compliance. If you are passionate about quality systems, process optimization, and regulatory excellence, this is an exciting opportunity to drive impactful change in a growing medical device company.

Key Responsibilities – Director of Quality Systems (Medical Device) in Memphis, TN

1. Develop and Maintain Quality Management Systems (QMS)

Establish, implement, and maintain QMS in compliance with FDA, ISO 13485, and other global regulatory requirements.
Continuously evaluate and improve quality processes, documentation, and risk management strategies.
Ensure QMS aligns with business goals and supports operational efficiency.

2. Oversee Regulatory Compliance and Audit Readiness

Lead internal and external audits, ensuring adherence to FDA, ISO, and other regulatory requirements.
Serve as the primary contact for regulatory agencies during inspections and compliance reviews.
Develop and execute strategies to address audit findings and maintain regulatory excellence.

3. Drive Continuous Quality Improvement Initiatives

Identify areas for process enhancements and lead initiatives to optimize product and operational quality.
Implement lean and Six Sigma methodologies to drive efficiency and reduce variability in production.
Foster a culture of continuous improvement across the organization.

4. Manage Risk and Non-Conformance Investigations

Oversee CAPA (Corrective and Preventive Action) processes to address quality issues and prevent recurrence.
Lead root cause analysis (RCA) and risk assessments to mitigate potential quality concerns.
Ensure timely resolution of non-conformances and deviations through structured problem-solving approaches.

5. Lead Supplier Quality Management Programs

Develop and maintain supplier quality programs to ensure compliance with regulatory standards.
Conduct supplier audits, evaluations, and performance reviews to ensure product quality.
Establish effective supplier relationships to drive collaboration and quality improvements.

6. Ensure Effective Training and Compliance Programs

Develop and oversee quality training programs for employees to ensure compliance with regulatory and quality standards.
Maintain accurate training records, documentation, and competency assessments.
Promote a culture of accountability and quality awareness throughout the organization.

7. Collaborate with Cross-Functional Teams for Product Quality Assurance

Work closely with R&D, manufacturing, regulatory affairs, and operations teams to maintain quality throughout the product lifecycle.
Oversee design control processes, validation procedures, and risk management strategies.
Ensure that quality requirements are integrated into new product development and process changes.

8. Monitor Quality Metrics and Performance Indicators

Establish and track key performance indicators (KPIs) for quality to measure effectiveness and drive improvements.
Provide data-driven insights and reports to senior leadership on quality trends, compliance risks, and performance outcomes.
Develop action plans to address quality gaps and drive operational excellence.

What The Client is Looking For in You

To succeed as the Director of Quality Systems (Medical Device) in Memphis, TN, you need a combination of technical expertise, leadership skills, and regulatory knowledge. The ideal candidate will bring:

Extensive Experience in Quality Systems and Compliance – A strong background in quality assurance and regulatory compliance within the medical device industry, including FDA, ISO 13485, EU MDR, and other global regulatory frameworks.
Proven Leadership in Quality Management – A demonstrated ability to develop and oversee quality systems, lead teams, and implement strategic initiatives to enhance product safety and compliance.
Strong Analytical and Problem-Solving Skills – Expertise in CAPA, root cause analysis (RCA), and risk management to identify and resolve quality issues efficiently.
Audit Readiness and Regulatory Interaction – Experience managing regulatory audits and inspections from the FDA and other agencies, ensuring seamless compliance and continuous improvement.
Supplier Quality Management Expertise – A track record of working with suppliers to establish quality standards, conduct audits, and enhance supply chain reliability.
Process Improvement and Lean Methodologies – Knowledge of Lean, Six Sigma, and process optimization techniques to enhance efficiency, reduce waste, and improve product quality.
Strong Communication and Cross-Functional Collaboration – The ability to work with R&D, manufacturing, regulatory affairs, and executive leadership to align quality initiatives with business goals.
Passion for Quality and Innovation – A commitment to continuous improvement, regulatory excellence, and advancing medical technology that improves patient outcomes.

Why This Opportunity Stands Out

This role offers a unique opportunity to lead and shape the quality strategy of a growing medical device company. As the Director of Quality Systems (Medical Device) in Memphis, TN, you will:

Be a Key Leader in a High-Growth Organization – Join a company that is expanding its market presence and investing in quality innovation.
Work on Cutting-Edge Medical Devices – Play a critical role in ensuring high-quality, safe, and effective medical technologies reach the market.
Drive Meaningful Impact on Healthcare – Your work will directly influence patient safety, regulatory success, and overall company growth.
Competitive Compensation & Benefits – Enjoy a highly competitive salary, performance-based bonuses, and executive-level benefits.
Lead and Develop a High-Performing Team – Work with dedicated professionals in quality assurance, regulatory affairs, and operations to elevate quality standards.
Influence Regulatory and Quality Strategies – Engage with regulatory bodies, lead compliance programs, and drive continuous quality improvement initiatives.
Collaborate with Industry Experts – Work alongside top engineers, regulatory specialists, and executive leaders to shape the future of medical device quality management.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, with experience in quality systems, regulatory compliance, and process improvements. Experience in biotech, diagnostics, or healthcare manufacturing is also valuable.

Q: What is the expected reporting structure?
A: The Director of Quality Systems (Medical Device) in Memphis, TN will report directly to the Vice President of Quality and Regulatory Affairs and collaborate with cross-functional leadership teams.

Q: What regulatory standards will I be responsible for?
A: This role requires expertise in FDA regulations, ISO 13485, EU MDR, cGMP, and global quality standards relevant to medical devices.

Q: Is relocation required for this position?
A: The position is based in Memphis, TN, and candidates must be open to relocation or already reside in the area.

Q: What are the key leadership expectations for this role?
A: We seek a strategic and proactive leader who can develop and enhance quality systems, drive compliance initiatives, and foster a culture of continuous improvement.

Q: What is the expected travel requirement?
A: This role may require domestic and occasional international travel, particularly for supplier audits, regulatory meetings, and quality system assessments.

Q: What qualifications and skills are required?
A: A bachelor’s or master’s degree in engineering, quality management, or a related field is required. A minimum of 10 years of experience in quality management, regulatory compliance, and leadership within the medical device industry is essential.

Q: How does this role contribute to the company’s overall success?
A: The Director of Quality Systems (Medical Device) in Memphis, TN, ensures regulatory compliance, enhances product quality, and drives operational efficiency, directly impacting company growth and market success.

Q: What is the timeline for hiring and onboarding?
A: The company aims to complete the hiring process within the next 60–90 days, with onboarding that includes training on current quality systems, regulatory requirements, and strategic quality initiatives.

What Remuneration Can You Expect from This Job?

As the Director of Quality Systems (Medical Device) in Memphis, TN, you can expect a competitive compensation package that reflects your leadership role and expertise in medical device quality management. The base salary for this position typically ranges between $150,000 – $200,000 per year, depending on experience, industry knowledge, and past achievements in quality systems, regulatory compliance, and continuous improvement initiatives.

In addition to the base salary, this role offers performance-based bonuses and incentives tied to key metrics such as regulatory compliance, audit success rates, process improvement efficiency, and overall quality system enhancements. Equity options or stock grants may also be available, providing a long-term investment in the company’s success.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, paid time off, and executive-level professional development opportunities. Additional perks may include relocation assistance, travel allowances, and participation in industry conferences.

This role not only provides a highly rewarding financial package but also offers the chance to drive meaningful improvements in medical device quality systems while working with a leading organization in the healthcare industry.

How to Apply for This Director of Quality Systems (Medical Device) Position in Memphis, TN

If you are an experienced quality systems leader with a strong background in medical device compliance, regulatory affairs, and process improvement, we invite you to apply for the Director of Quality Systems (Medical Device) in Memphis, TN. This is an exceptional opportunity to lead quality assurance initiatives, optimize compliance strategies, and contribute to a growing medical device company.

To apply, please submit your resume and a cover letter detailing your experience in quality management, regulatory compliance, risk mitigation, and process optimization within the medical device sector.

This role offers a rewarding opportunity to drive high-quality manufacturing standards, regulatory excellence, and operational efficiency in a dynamic and innovative environment. Apply today to take the next step in your executive career as a Director of Quality Systems (Medical Device) in Memphis, TN!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.