Director, Quality Assurance

Location: Savannah, GA

Department: Quality Assurance

Reports To: Executive Leadership

Summary of the Role

The Director of Quality Assurance is responsible for leading and evolving quality systems across multiple manufacturing and distribution entities. This role ensures compliance with global regulatory standards, including ISO 13485, ISO 9001, FDA QMSR, and EU MDR. The Director will serve as a key regulatory liaison and oversee internal and external audits, supplier quality, and strategic quality initiatives across the organization.

Key Responsibilities

• Lead and manage quality assurance audits across manufacturing sites, distribution centers, and external suppliers.

• Oversee Quality Management Systems (QMS) to ensure compliance with MDSAP and other international regulatory frameworks.

• Serve as the Management Representative and Person Responsible for Regulatory Compliance (PRRC) under EU MDR.

• Act as the FDA Official Correspondent for U.S. facilities and U.S. Agent for foreign entities.

• Direct supplier quality oversight, including performance monitoring and CAPA follow-up.

• Support product and process transfers in compliance with applicable standards and regulations.

• Lead internal and external audits, including private label manufacturers and joint ventures.

• Develop and implement quality systems such as CAPA, design control, and process control.

• Provide strategic direction and mentorship to the quality team.

• Collaborate cross-functionally to align quality processes with operational goals.

• Assess and improve existing policies, procedures, and quality standards.

• Participate in due diligence and surveillance audits for manufacturing partners.

Minimum Requirements

• Deep understanding of ISO 9001, ISO 13485, FDA QMSR, and EU MDR 2017/745.

• Experience managing QMS across multiple manufacturing locations.

• Strong leadership, communication, and decision-making skills.

• Ability to manage complex projects and influence cross-functional teams.

• Strategic planning and budget management capabilities.

Education & Experience

• Bachelor's degree in Engineering, Science, or a related technical field required; Master's degree preferred.

• Minimum of 10 years of progressive experience in quality assurance, including 5+ years in a leadership role.

• Professional certifications (e.g., RAPS, ASQ) preferred.

Supervisory Responsibilities

• Direct supervision of senior quality professionals and department managers.

Safety & Incident Management Responsibilities

• Enforce safe work practices and ensure compliance with safety protocols.

• Lead incident response efforts and coordinate with EHS for investigations.

• Conduct root cause analyses and implement corrective actions.

• Ensure timely completion of safety reports and documentation.

Work Arrangement & Travel

• This is an on-site role based in Savannah, GA.

• Travel up to 25% may be required.

Benefits

• Medical, Dental, and Vision Coverage

• 401(k) Plan with Company Match

• Generous Paid Time Off & Paid Parental Leave

• Income Protection & Life Assistance Programs

• Flexible Spending Accounts

• Educational Assistance & Scholarship Programs

• Volunteer Opportunities