Quality Assurance Specialist
3 dni temu
At Smith+Nephew, we are driven by a shared purpose to restore people's bodies and minds. We are looking for a Quality Assurance Specialist with expertise in EU compliance to join our team in Warsaw.
Job Description:The Quality Assurance Specialist will be responsible for maintaining and managing the Quality Management System (QMS) for relevant sites to ensure compliance and effectiveness. This includes developing, reviewing, and enhancing quality processes and procedures for clarity, compliance, and operational efficiency.
The ideal candidate will have a strong understanding of Good Distribution Practices, attention to non-conformities, and the ability to assess products against specifications. They will also possess excellent documentation, communication (written and verbal), and teamwork skills, with the ability to work independently as needed.
Key Responsibilities:- Maintain and manage QMS for relevant sites
- Develop, review, and enhance quality processes and procedures
- Represent and support Quality and Regulatory Affairs (RA) processes during audits
- Administer Corrective and Preventative Action (CAPA) and Non-conformance (NC) systems
- Report monthly on quality and regulatory metrics
- Bachelor of Science degree with solid knowledge of EU Medical Device Regulation (2017/745)
- Accredited Quality certificate, ASQ certification, or equivalent preferred
- 2–4 years of experience in inspection activities or similar roles within a regulated industry under a Quality Management System
- Strong understanding of Good Distribution Practices and ISO 9001:2015
We offer a dynamic work environment, opportunities for growth and development, and a comprehensive benefits package. If you are a motivated and detail-oriented individual with a passion for quality assurance, please submit your application.
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