Material Analyst Biocompatibility

For our customer, a medical technology manufacturer in Graubünden, we are looking for a
Material Analyst Biocompatibility, 80 - 100% (f/m/d)
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

Your qualifications:

• 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 application
Please apply online. For further information about the position, please contact your Kelly recruiter, Ms. Susanne Junker, (+41 76 335 16 58).
About Kelly We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.