Advanced Quality Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Advanced Quality 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)
Responsible for the design, modeling, development and testing of a machine, structure or system. Develops functional requirements. Understands and applies standard engineering principles. Creates simulations and prototypes to evaluate preliminary designs and test how a machine, structure or system operates. Designs and tests components, and integrates components to produce final product. Monitors quality of products and controls the efficiency of processes. Evaluates a design' s overall effectiveness, cost, reliability, and safety. Investigates root causes of failures to maintain quality and recommend improvements.
AQE will support the project teams handling the integration of several new acquisitions and will support DHF and Risk integration and remediation. This position is for 1 year with the potential to convert to direct hire. This contractor will work with New Product Development and Integration teams to conduct engineering activities to ensure quality standards and goals are met for acquired products.
Engineering Degree + 1 year in medical device or similarly regulated industry.
Time in internship or co-op is accepted.
Strong engineering aptitude, communication skills, attention to detail.
Experience with new product development utilizing a Quality System conforming to ISO 13485 or similar.
Experience with medical device Design Controls, Risk Management, and Design History Files.
Drawing standards and GD&T per ASME Y14.5M-1994 or later
Working knowledge of ISO 14971 Risk Management or similar
Working knowledge of process development standards (e.G. PFMEA, Process Validation, etc) Ideal candidates will have exposure to new product development documents like risk management files (RMF), DFMEA, PFMEA, validation, etc.