Title: Packaging Engineer

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.

* Establishes and tracks critical milestones, timelines and contingency plans

* Follows up throughout project process to ensure project goals are achieved

* Seeks out continuous improvement opportunities and oversees timely implementation of efficient manufacturing practices.

* 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.)

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

* 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:

* Fluent English

* Strong knowledge and skills in MS Office

* Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
12/2021
Dauer
12 Months
Von
Michael Bailey Associates
Standort
Solothurn
Eingestellt
26.11.2021
Projekt-ID:
2260091
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