Permanent

Posted 2 weeks ago

Recruiter: Christoph Bally

The Life Science Career Network – CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

For our client, a MedTech company based in the Grisons, Switzerland, and to support its R&D activities, we are looking for a

Material Analyst Biocompatibility 80–100% (5901)

Tasks and Responsibilities:

– Support R&D with material selection for critical components wrt ISO18562-1-4/10993-1-23 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 QM 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

Requirements:

– Degree in an engineering discipline or equivalent non-technical degree with experience in chemical or materials manufacturing, engineering or QA

– Familiarity 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 V&V 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

Interested? Contact me!

Material Analyst Biocompatibility 80 - 100 % (f/m/d) (5901)