Sr. Quality Assurance Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. 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
This role will be supporting a project that is just getting out of the early design phases, responsibilities will include implementing Risk Management System to asses Usability, print reviews, process validation (equipment/fixture validation)
Guide NPI teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
Involved in developing, modifying, and executing design controls per company guidelines and procedures.
Provide input throughout the new product development process from a quality perspective
Lead risk management for project including risk analysis and development of sound mitigation strategies
Lead efforts for usability and human factors engineering
Collaborate with Design Engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
Support process and product validation programs for new product development
Educate NPI team on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
May perform supplier development activities surrounding PPAP
Develop and create procedures for incoming, in-process and final inspection of components and finished goods
May have involvement in continuous improvement projects for the organization
Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization.
Looking for candidates with at least 3+ years experience working with Quality or New Product Development (NPD) within the Medical Device Industry.
Bachelor s in mechanical/Electrical/Biomedical Engineering Required