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Job description
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.
What You Will Need
Required Qualifications
- 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).
Preferred Qualifications
- 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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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