This role is accountable for building, maintaining, and continuously improving a Quality Management System that meets global medical device regulatory requirements. As a Senior Specialist, you will guide QMS development and execution across the organization, ensuring regulatory readiness, audit compliance, and alignment with corporate quality standards.
Ensure Quality Management System (QMS) compliance with applicable internal and external regulatory requirements, including site, corporate, FDA, ISO, EU MDR, and country‑specific regulations.
Develop, implement, and control updates to regional and local quality management system processes aligned with corporate and divisional QMS requirements.
Support the management and coordination of internal and external audits, including preparation, execution, and follow‑up activities.
Coordinate and lead Management Review forums in accordance with applicable procedures, including preparation of meeting minutes and follow‑up action items to closure.
Participate in the development, maintenance, and continuous improvement of quality policies and procedures.
Review and approve quality compliance documentation, including non‑conformances, corrective and preventive actions, and change controls, as required.
Manage document control activities, including routing, release, distribution, archiving, and retrieval to ensure current documentation is available as required.
Coordinate regulatory correspondence and additional information requests from health authorities and customers, including notifications to corporate regulatory and quality teams.
Required
Bachelor’s degree in engineering, science, or business administration.
Minimum 4 years of regulatory or quality systems experience within the medical device industry or another FDA‑regulated manufacturing environment.
Prior experience working in a legal, technical, or regulatory environment.
Proficiency in English and Spanish (written and verbal, business level).
MS Office knowledge
Preferred
Quality or regulatory certification (e.g., Certified Quality Auditor, Certified Quality Engineer, Six Sigma).
Certified Lead Auditor for ISO 13485:2016.
Experience working with electronic quality or document management systems.
Skills Required
- Bachelor's degree in engineering, science, or business administration
- Minimum 4 years of regulatory or quality systems experience
- Prior experience in a legal, technical, or regulatory environment
- Proficiency in English and Spanish
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
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Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
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Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.
Stryker Insights
What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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