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Compensation Not Specified
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Required Education None
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Required Experience Less than 1 year
Job Details
Requisition ID 657BR Job Title RAQA Specialist GSAP Group International Division Europe Business Unit GSAP Business Function Regulatory Affairs Country GERMANY City Duisburg Employment Category Full Time Percent Travel Required Up to 10% Shift Other About Stryker Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. Job Description / Information Quality Management System - follow up of the EU SOP demands and realize considering the strictly guideline - Leading OMS projects to improve business processes - Responsibility for achieving the Corporate and local KPIs - Communication point between sales, production and other 3rd parties - Participation in all local and European RA/QA Team meetings - Training of internal employees according to local and corporate procedures - perform internal audits - Implementation support of ISO 9001/ISO13485 and GDP - supporting CAPA and complaint activities Post Market - Performing Product Holds and Product Field Actions - Communication with local competent authority’s Pre Market - Support new product launches - Ensure timeless approval of marketing materials Minimum Qualifications - minimum 3 years in a RAQA environment of a medical company - proven knowlage and experience with ISO9001/13485 - knowlage with MDD and MPG - experience as a project manager - technical or ecomical degree with serveral years experience in RA/QA - fluent german and english