Beschreibung
For our client in Zuchwil we are looking for a Packaging Engineer for a 12 months project
By May 27th,2024, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)
OVERALL 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/Windchill)
- Support Shelf Life activities and create/update shelf life specific documentation for Eu and US
POSITION DUTIES & RESPONSIBILITIES:
- Review and update technical reports, procedures, policies and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements and current technology
- 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
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) for shelf life related change requests through Agile PLM software
- Technical understanding (drawings, processes, packaging specifications and materials, validation standards (ISO11607, ISTA3A, ASTM standards for testing ), 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
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- at least 4 years' work experience in an adequate position and regulated industry preferred
- Experience in an Medical Device regulated environment, package qualification or quality eng. department a plus
- Background on validation procedures and packaging technology
- Proven exceptional written and oral presentation skills
EDUCATIONAL REQUIREMENTS:
- Bachelor's degree in engineering or related discipline, or equivalent and extensive related project experience
- Certificates in Program/Project Management will enhance candidacy but are not a
requirement
OTHER REQUIREMENTS:
- Strong knowledge and skills in MS Office
- Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy
- Must be highly organized, creative, articulate and analytical
- Strong interpersonal and diplomatic skills
- Ability to multi-task independently with minimal supervision