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Your challenge 
To assure the Quality and Safety of Innovative (Medical and Non-Medical) products in a Dynamic Environment. 
Key challenges include risk management, design quality assurance activities and co-ordination of quality activities with Engineering, procurement, manufacturing, clinical, service and support teams. Supports organization to work compliant in a lean way. 

Your responsibilities 
• Instruct, coach and facilitate project team’s w.r.t Innovation Site Eindhoven-Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.). 
• Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.) 
• Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements 
• Create quality function deliverables as per Innovation Site Eindhoven-Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance. 
• Review Requirements Management process and outcome. 
• Reviews Product Verification and Validation. 
• Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.). 
• Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility. 
• Ensures timely execution and required communications and escalation. 

Your team 
You will be part of the Q&R team consisting of approximately 40 team members working for the businesses- Mother &Child Care, Skin Care, Health Measuring Devices & Pain Relief reporting to the QAM Group lead. You will be based in Eindhoven, The Netherlands. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across the organisation. 

 

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