Our client, a swiss family company - based in Root (LU) -, market-leading expert in regeneration (Cartilage, Bone, Soft Tissue) for orthopedics, dentistry and drugs, is seeking an interdisciplinary operating personality in the position as
Design Control & Product Risk Manager (partly remote based)
- Process owner for the Design Control (DC) process for medical device development according to ISO 13485 and the Product Risk Management (RM) process according to ISO 14971
- Representation of processes and Design History Files (DHF) in internal and external audits
- Management and documentation of product designs (DHF), design changes, product related corrective actions (CAPAs) and product phase outs
- Management and documentation of product risk files
- Support of change and product maintenance projects
- Academic background in life sciences, pharma technology or equivalent
- Experience in medical device development, DC and RM
- Experience in DHF, CAPA and RM file documentation
- Strong self-starter with pioneering spirit, willingness to shape the own area of responsibility, resilient, strong executer and communicator
- Keen to learn newest technologies in research and IT
- Interdisciplinary communication
- Fluent in English (written and spoken), German of advantage
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr. Andreas Danner, Dr. med. Dipl.-Biol. (+41 44 225 41 07).
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.