Michigan, Kalamazoo-Battle Creek
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Manufacturing Engineer for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
The purpose of this role is to support the project to make Improvements and updates to operations / manufacturing instructions, routes and inspection criteria. Assessment of existing tech files to identify gaps and remediate accordingly. All in an effort to be compliant with updated EUMDR requirements.
Top 3 MUST-HAVE qualifications
o 1. Understanding of manufacturing operations within a regulated environment
o 2. Prioritize and execute independently once on board.
o 3. Experience with in process controls, validation, control plans, DHR creation etc.
Top 3 desired qualifications:
o 1. Medical device experience
o 2. Change control experience
o 3. Solid non-expert regulatory knowledge FDA, ISO 13485, EUMDR T
There will be 2-3 weeks of ramp up. Expectations after training is completed: Understand the project scope and status. Work with existing contractor to get up to speed on systems and processes. Gain access to appropriate systems. Meet appropriate players. Begin completion of actions per project plan. Escalate concerns, needs or roadblocks.
Bachelors degree required
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