Material Analyst Biocompatibility (m/f/d)

Your Profile:

• Degree in an engineering discipline or equivalent non-technical degree with experience in chemical or materials manufacturing, engineering or quality assurance
  
• You are familiar with: materials regulatory framework in EU, US and ROW, including but not limited to: MDR 2017/745, REACH, ROHS, POP, California Proposition, Conflict minerals, TPCH
  
• Qualified verification and validation engineer, who can lead, acknowledge, develop, communicate & implement materials testing strategies to ensure compliance to Medical Device requirements
  
• Effective problem solver, with the skills to lead Root Cause investigations plan complex workstreams and influence others cross-functionally
  
• Ideally, you gained first-hand experiences in dealing with complex regulations and compliance requirements for legal entities and products designed, developed, manufactured, distributed and sold by those entities in ideally global markets
  
• Able to use English and German as working language, excellent communicator and collaborator who can influence at all levels of the organization
  
• You have experience with: ISO 10993-series, preferably also with ISO 18562-series of standards

Your Tasks:

• Support R&D with material selection for critical components in relation to ISO 18562-1-4, ISO 10993-1-23 and in conformity with global legislations related to material compliance
  
• Support the implementation of material compliance data management
  
• Contribute to supplier quality by providing input to quality management agreements in relation to material compliance and biocompatibility
  
• Support material changes and set up internal processes for managing changes efficiently
  
• Support and document V&V activities in materials testing related to chemical and biological safety for product lifecycle management, change management and new product development
  
• Assisting with any potential product field re-engineering, corrective action, related to material compliance topics, including necessary support to regulatory agencies and customers
  
• Collaborate with Suppliers and internal Stakeholders to drive Quality improvements that minimize the Costs of Quality and support implementation of Supplier/Engineering changes, New Product Introductions and Transfers

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