Quality Assurance Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Quality Assurance 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.
Summary of role
Sound technical competence required to ensure the delivery of robust products/processes.
Support process validation programs for new/existing product development.
Execute quality engineering tasks and provide input about quality throughout the new product development process.
Supplier development activities surrounding the Production Part Approval Process (PPAP.)
Create and update inspection procedures for incoming components and assemblies and finished goods.
Lead risk analysis and develop mitigation strategies.
Collaborate with design engineers to develop robust verification test strategies to ensure safe and reliable products.
Guide new product development teams through the quality system to ensure products are developed in compliance to their procedures and the requirements of the FDA, ISO, and other regulatory bodies.
Bachelors degree in Mechanical/Electrical/Biomedical Engineering required.
Role will take process ownership over the AQE role working with external site who owns design to prepare it for manufacture in Kalamazoo.
Looking for entry level engineering candidates with 0-1 years of experience in Medical Device or Manufacturing Engineering.
Internships will be accepted in the place of post-graduate work-experience