Quality Engineer II

Viant Medical, LLC seeks a FT Quality Engineer II based in Wilmington, MA responsible for overseeing the dev. of qual. standards and protocols for qual. assurance testing models. This position will also be assisting with the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.   Requirements:  Master’s degree or equiv. in Mechanical Engineering, or a related field and must have 2 years related exp. Must also have 12 months of exp. with each of the following: (1) Applying knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and ISO 17025; and implementing company qual. policies and procedures of the Qual. Mgmt. System and ensuring compliance with the same; (2) Developing and maintaining key qual. deliverables for projects, including Risk mgmt. files, Master Validation plans, Qual. plans, Incoming and In process inspection plans, SOP's, and other qual. records related to Design and Dev. of medical device products; (3) Defining the requirements for the Component Qualifications and managing Product Part Approval Process (PPAP) submissions for new production parts; (4) Performing validation activities including Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) for process, equip., facility and utilities as req.; (5) Creating and validating Test Methods to eval. product perf. and effectiveness using statistical analysis tools like Analysis of Variance (ANOVA) and Gage Repeatability and Reproducibility (Gage R&R); (6) Conducting thorough statistical analyses utilizing Minitab and Six Sigma tools like Process Mapping, 5-Why, or FMEA to eval. process capabilities and recommend process improvements. Will accept exp. gained before, during, or after Master's program. Will accept exp. gained concurrently.   This position includes a telecommute benefit within commuting distance of this office. Please apply online at viantmedical.com/careers/us-jobs/.