Experience Requirements
This individual will have a minimum of five years of professional quality engineering experience, preferably in medical device development.
Qualification Requirements
Bachelors Degree in Quality Engineering or closely related field. Prefer Masters of Science Degree.
Preferred Qualifications
Master of Science and CQE preferred.
Responsibilities
Under general direction, the Quality Engineer is responsible for performing the following Quality Engineering functions: Support the Product Development Group in multiple new and sustaining engineering projects, insuring assigned deliverables are completed in a timely manner. Participate in design reviews, and helps provide creative solutions. Provide Quality Engineering support for existing product design modifications, general design control, product transfers to production, and product transfer between internal or external manufacturing sites.
Responsible to ensure product development efforts are in compliance to established quality standards, operating policies and procedures.
Implement the site Quality System and establish procedures as appropriate in compliance to FDA regulations and ISO requirements. Provides interface with Regulatory Department to help establish product specifications for agency compliance (FDA, ISO, IEC, etc.) and ensure compliance to these standards are met within the product development efforts. Initiate and recommend improvements to designs, processes, documentation, materials and manufacturing processes to improve product quality. Provide product development protocol requirements for quality standards, inspection techniques and inspection frequencies, lot sizes, statistical analysis, sterility requirements, etc.
Provide liaison and work closely with customers, vendors, Product Development Engineering, Regulatory and Production Departments at the site(s) of manufacture to resolve quality problems. Support the generation of incoming, in-process, and/or final inspection documents and procedures in support of Purchased Finished Goods. Provide data and guidance to the site Material Review Board in the disposition and resolution of discrepant materials related to design or use issues. Provide technical and service complaint investigation support to Medical Affairs as it relates to customer complaints as requested.
Use statistical techniques to trend quality performance for newly launched products or product modifications, identify quality problems and help improve internal efficiency. Supply quality metrics as requested. Must be able to demonstrate creativity and ingenuity in applying engineering principals and practices as well as effectively present information and respond to questions from groups of managers, clients, customers and general public.
