Stryker · 1 day ago
Staff Quality Systems Specialist
Sandy Springs, GA
Full-time
Hybrid
Senior Level, Lead/Staff
4+ years expStryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine, impacting over 150 million patients annually. They are seeking a Staff Quality Systems Specialist to lead initiatives ensuring medical devices meet global standards, focusing on patient safety and regulatory compliance.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
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
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
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase