Work Flexibility: Hybrid
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.
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.