Quality Engineer

Multi-billion dollar market-leading Medical Device firm needs you for a challenging opportunity as they ramp up for numerous next generation Class II and III product platform launches! Our client has maintained impressive growth and tremendous reputation for over 100 years and yet they still make Fortune's list of most innovative Companies. They set themselves apart with their commitment to inventing new materials, engineering new technologies and pioneering ways to remain ahead of the competition. Now is time to set yourself apart from the competition and microwave your career in a unique opportunity to support one of the Medical device industry's most impressive new product development pipelines by applying all of your Advanced Quality Engineering, Project Management and intangible skills to thrive in a rapid-paced environment at a company providing the growth and strength to build your future.

The Senior Quality Assurance (QA) Engineer will work in the organization as part of the Research and Development (R&D) QA group and will be the primary liaison between QA, R&D, and/or Operations on projects/programs requiring design control. You will have the opportunity to work with various disciplines as a team in order to arrive at solutions that support the company business objectives and quality standards. Will guide and influence new product teams through design, validation and verification, and interfaces to regulatory compliance and assures robust product vs. customer/product requirements. Implement design control policies and procedures for a program or project. Instrumental in developing effective quality and design practices through process reengineering and science based practices. Drive implementation of efficient FDA QSR processes for quality, regulatory, hardware design, software design, manufacturing and servicing. Help establish engineering rigor, product design assurance and reduced post-launch design issues. Work with production to ensure a technology transfer of devices in preparation for commercialization. Ensure product development teams adhere to FDA design controls. Provide quality engineering guidance in multiple projects as products are transferred from R&D to manufacturing.

B.S. degree required, preferably in an Engineering discipline. Must possess a minimum of 3-5 yrs QA experience in the Medical Device manufacturing or pharmaceutical industries. Experience in supporting post launch product and process changes. Knowledge and experience with validation and verification activities, manufacturing practices, and statistical techniques. Design Control experience is MANDATORY for this position, as well as possessing a good working knowledge of applicable regulations and standards such as FDA QSR, ISO, MDD, IVDD, etc.. Must be able to define design document requirements for product/ process and specified Design Control Requirements. Understands, implements and maintains quality policy, ensures compliance to and is able to demonstrate knowledge of site level policies and procedures, related to Design Control projects. Must be competent in data analysis and interpretation to make data driven decisions when providing guidance, recommendations and decisions. Fully understand the quality and regulatory aspects of medical device design and manufacturing including quality assurance, product V&V, use of recognized standards and compliant design practices. In depth experience regarding the impact of design decisions on total lifecycle costs and time to market.