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Stryker · 1 day ago

Staff Quality Systems Specialist

Sandy Springs, GA

Full-time

Hybrid

Senior Level, Lead/Staff

4+ years exp

Stryker 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

Growth Opportunities

H1B Sponsor Likely

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

Quality Management SystemsRegulatory requirementsAudits managementProject managementProfessional certifications

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

Glassdoor4.1

Stryker is a medical technology company that offers products and services in orthopaedics.

Founded in 1941

Kalamazoo, Michigan, USA

10001+ employees

http://www.stryker.com/en-us/index.htm

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)