Warsaw, POL
4 days ago
Senior RAQA Specialist (fixed-term contract until the end of 2026)
**What you will do** + Implementation and maintenance of QMS compliant with ISO 13485:2016. + Managing QMS documentation. + Managing CAPAs, non-conformances, complaints and other quality related activities. + Managing suppliers. + Lead internal audits. + Support external audits for ISO 13485:2016 certification. + Cooperating with operations and post market surveillance team. + Representing quality assurance and quality management within the business. **What you need** Required: + 2–3 years of experience in the medical device industry + Knowledge of medical device quality management systems and regulatory compliance + English and Polish full professional proficiency + Knowledge of documentation lifecycle, risk assessment, and change management + Strong problem-solving abilities and experience in root cause analysis (RCA) and corrective action/preventive action (CAPA) Preferred: + Certified Lead Auditor within ISO 13485:2016 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 150 million patients annually. 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.
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