Description
Packaging Engineer - Med. Devices -SwitzerlandIf you would like to improve yourself and use your technical skills in a global active and well known company, Real Staffing has the perfect opportunity for you.
Our client, is one of the market leaders in medical devices for orthopaedics, advanced wound management and clinical therapies.
For a project in the north-central of Switzerland we are searching a Packaging Engineer
Your key responsibilities will be:
- Overview the complete process from designing, specifying and verifying of various packaging designs (acc. ISO 11607).
- Coordinating specifications and requirements for new packaging equipment
- Optimisation, standardisation, harmonisation of established packaging configurations.
- Designing, testing and generation prototypes as well as documentation and implementation of sterile and non-sterile packaging system for all company medical devices and instruments
- Development of processes (business) to be compliance acc. 21 CFR 820 and ISO 13485
- Design Dossiers (DHF) and Tech-Files, Packaging specification, Design verification Shelf Life Testing, sealing DOEs and process validation acc. ISO
- Transfer the complex packaging solutions into commercial facilities / packaging centers
- Bringing packaging materials to commercialisation and complete or implement complex packaging solutions.
- Corrective and Preventive Actions (CAPA) regarding the mentioned processes
- Provide project management for support of new product introductions, line extensions and external development alliances
- Responsible for the packaging documentation
Requirements:
- Master in Packaging Engineering or comparable education
- Experienced with processes (Design Control, Reports etc.) according ISO13485 and 21CFR 820
- Subject Matter Expert (SME) for every packaging related activity
- Experience with CAPA, Complaints, Change Management, internal and external audits, p- and d- FMEAs
- German and English fluent
If you bring a specialization in packaging acc. 11607 for medical devices, I would be delighted to have a confidential discussion about your options for progression.
If this opportunity sounds interesting, do not hesitate to contact me for more details or send me your CV.
For more information on this or other opportunities contact Marco Heumann, at Real Staffing Group, Zürich