Packaging Engineer - Medical Devices/EU MDR , Solothurn Sentinel IT LLPHELP
|Beschreibung:||Packaging Engineer - Medical Devices/EU MDR|
|Firma:||Sentinel IT LLP - Firma bewerten|
|Salär:||zu verhandeln CHF - 40 Std/Woche|
Packaging Engineer - Medical Devices/EU MDR
Leading global Pharma conglomerate require a Packaging Engineer to assist with a project aimed at bringing their Medical Device subsidiary in line with EU Medical Device Regulations (EU MDR).
* By May 26th, 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)
* Liaise with all key stakeholders when formulating and communicating the Project Plans.
* Ensure continually 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)
POSITION DUTIES & RESPONSIBILITIES:
* 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.
PROFESSIONAL EXPERIENCE 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
* Proven exceptional written and oral presentation skills
* 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
* 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
Please apply now for more details!