Beschreibung
We are looking for a Packaging Engineer for a Global Medical Device company based in Zuchwil, you will be working on the new MDR projects to get ready for May 2020.Responsibilities:
- Liaise with all key stakeholders when formulating and communicating MDR Project Plans by ensuring continuous deployment of the MDR Plan through consistent excellence in project management.
- Ensure availability and correctness of packaging documentation for sterile and non-sterile medical devices, in compliance with all valid regulations (ISO, MDR, FDA, etc.)
- Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
- Perform updates/changes (DCR/DCO) for non-conforming packaging documents and Bill of Materials in the systems (Agile/SAP)
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) for all packaging related change requests through Agile PLM software.
- Technical understanding (drawings, processes, packaging specifications and materials, validation standards, etc.)
- Initiate, route, verify and handle all the administrative paperwork and formalities in coordination with multiple departments stakeholder contacts.
Requirements:
- 2+ years' work experience in an adequate position and regulated industry preferred
- Experience in a Medical Device regulated environment
- Background on validation procedures and packaging technology
- Bachelor's degree in business, information systems or related discipline, or equivalent and extensive related project experience.
- Certificates in Program/Project Management will enhance candidacy but are not a requirement
- Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.