Posted on Aug 27, 2019 by Experis AG
Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.
One of our clients, a leader in the Medical Devices industry, is looking for a Packaging Engineer for a 12-month contract based in Solothurn, Switzerland.
By May 26th, 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR).
Your tasks & responsibilities
- 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)
- Plan, schedule and track project timelines using appropriate tools
- 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
- Additional duties as assigned
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
What you must have
- Bachelor's degree in business, information systems or related discipline, or equivalent and extensive related project experience
- 2 years' work experience in a similar position
- Experience in a Medical Device regulated environment
- Background in validation procedures and packaging technology
- Proven exceptional written and oral presentation skills
- Strong knowledge and skills in MS Office
- Must be highly organized, creative, articulate and analytical
- Strong interpersonal and diplomatic skills
- Ability to multi-task independently with minimal supervision
Nice to Haves
- Certificates in Program/Project Management
- Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP
- Swiss German spoken and written
- Start date: 01.09.2019
- End date: 31.08.2020
- Work location: Solothurn
- Workload: 100%
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Alexander Russell.