The ideal candidate will have experience in a similar role, i.e., will be technically gifted and have a good understanding of quality system regulations, manufacturing process validation process, and have a manufacturing background.
Based in Swords, Dublin, this company are offering a competitive salary and lucrative benefits package for the successful candidate. This is a great opportunity for those looking for career progression within a world renowned multi-national company.
*Able to develop test strategies, apply industry best practices, and self-manage to proactively drive and deliver testers to meet critical business milestones.
*Must be able apply mechanical engineering principles towards test fixture design while incorporating FDA regulatory and site quality system requirements into the process activities and design elements. The ability to synthesize multiple sources of business and technical requirements to produce an optimized solution is key.
*Ability to effectively engage, influence, set priorities and manage the expectations of the cross-functional teams that provide inputs to the tester development process or are stakeholders of the finished product.
*Create documentation packages and track the procurement of material.
*Ability to create and execute project schedules.
*Ability and experience on project schedule reporting to management
*Ability to create testing device functional specifications and communicate specifications with hardware software developers
*Ability to read and create testing electrical schematic diagrams
*Understanding of manufacturing process validation.
*Experience in design and manufacturing in a new product development environment.
*Experience in developing and implementing design of test and assembly fixtures.
*Interface experience with R&D, Manufacturing, Supply Chain, Quality and Regulatory functions.
*Excellent written, oral, planning and interpersonal communication skills with the ability to discuss or explain design features or issues with all level engineers, designers and drafters.
*Can work independently in a fast paced new product development environment.
*Highly self-motivated, self-directed, team orientated, and exceptionally attentive to detail.
*Proactively resolves issues in a timely manner so that they do not affect project timelines.
*Proficient current industry software and Microsoft Office.
*Expert in ISO and/or FDA quality system regulations
*Expert in Manufacturing process validation process
*Manufacturing background experience with material incoming inspection, process knowledge.
*Ability to communicate with cross functional teams within Operations/Manufacturing
*Medical equipment manufacturing background
If this sounds like an opportunity that you would be interested in please feel free to get in touch!
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
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♦ The business of the Adecco Group UK & Ireland is transacted via a number of differently branded trading entities, as follows: Adecco UK Limited, Adia Technology Limited, Modis International Limited, Badenoch and Clark Limited, Ajilon (UK) Limited, Office Angels Limited, Penna plc, Pontoon Europe Limited, Roevin Management Services Limited, Spring Technology Staffing Services Limited.