Sr. Quality Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr. 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.
Medical device experience is essential, 3 years minimum, 5+ years ideal
Some experience with remediation efforts and aligning to, creating, or following a project plan (PM experience)
Strong experience with Change Control and what it takes to make change within a regulated environment (this initiative will result in significant change, in particular a large volume of small changes)
Experience with Operations Engineering tools and their creation such as DHR s and routes, Process Mapping, DFMEA contribution, PFMEA contribution, control plans and inspection.
Strong communication skills and a solid (non-expert) understanding of the regulations associated with Med Device. This individual should be very involved in the why and help communicate the message and the importance of work
This person will interface with division, understand the ask and help drive to completion on the operations side.