Beschreibung
We have an opportunity for a project manager, with experience in packaging area for medical devices to manage communication and flow of information and execute the strategy plans.
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)
. 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.
Requirements
. Bachelor's degree in business, information systems or related discipline, or equivalent and extensive related project experience.
. Certificates in Program/Project Management is a plus. Experience in an Medical Device regulated environment
. Background on validation procedures and packaging technology
. Proven exceptional written and oral presentation skills
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 send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.