Staff Quality Systems Specialist

Stryker • Sandy Springs, GA

3d • Hybrid

About The Position

Staff Specialist, Quality Management Systems (QMS) Sandy Springs, GA Shape the future of quality excellence. In this role, you’ll lead initiatives that ensure our medical devices meet the highest global standards. Your work will directly impact patient safety, regulatory compliance, and operational efficiency, making a difference in healthcare worldwide. If you’re passionate about building robust systems and driving continuous improvement, this is your opportunity to make an impact. Work Flexibility: Hybrid: Candidates must reside within a commutable distance to Sandy Springs, GA and be able to work onsite several times per week. What You Will Do Develop and maintain a compliant Quality Management System (QMS) aligned with global regulatory requirements, including FDA, ISO, and EU MDR. Oversee QMS compliance across internal and external audits, ensuring successful outcomes and timely corrective actions. Manage certification processes by liaising with notified bodies and regulatory authorities. Lead QMS improvement projects to optimize processes for current and future business needs. Serve as Local Process Owner for quality system processes and ensure effective implementation. Coordinate management reviews and quality planning sessions to drive strategic decisions. Implement QMS training programs to ensure organizational understanding and adherence. Create, update, and maintain policies, procedures, and work instructions to meet regulatory and corporate standards.

Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• 4+ years of experience in Quality Management Systems within a regulated industry.
• Knowledge of regulatory requirements for medical devices (FDA, ISO 13485, EU MDR).

Nice To Haves

• Master’s degree in Regulatory Science or related discipline.
• Experience managing audits and certification processes.
• Familiarity with global regulatory frameworks and best-in-class QMS practices.
• Project management experience in QMS development or improvement initiatives.
• Professional certifications such as ASQ Certified Quality Auditor (CQA) or ISO Lead Auditor.

Responsibilities

• Develop and maintain a compliant Quality Management System (QMS) aligned with global regulatory requirements, including FDA, ISO, and EU MDR.
• Oversee QMS compliance across internal and external audits, ensuring successful outcomes and timely corrective actions.
• Manage certification processes by liaising with notified bodies and regulatory authorities.
• Lead QMS improvement projects to optimize processes for current and future business needs.
• Serve as Local Process Owner for quality system processes and ensure effective implementation.
• Coordinate management reviews and quality planning sessions to drive strategic decisions.
• Implement QMS training programs to ensure organizational understanding and adherence.
• Create, update, and maintain policies, procedures, and work instructions to meet regulatory and corporate standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees