Responsibilities:
• Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.
• Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment.
• Develop test plans, inspect, and assess material’s compliance based on dimensional and attribute acceptance criteria, while documenting and communicating inspection results.
• Determine optimal measurement devices to perform inspections. Understand AQL tables and how to select the correct sampling rate based on quality criteria.
• Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing
• Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
• Lead the development and implementation of visual and physical inspections of injection molded, mechanical, electrical, and packaging components to ensure they meet specifications.
• Assist Quality Engineers and manufacturing personnel with calibration activities, which includes reviewing and retrieving calibrated equipment necessary for processing
• Managing Root Cause Analysis activities stemming from MRB, RMA, and CAPA.
• Analyzing/trending non-conformances through NCMRs and RMAs.
• Assist in supplier audits and visits, as required.
• Assist in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).
• Support other duties as assigned by manager.
Required Knowledge/Skills, Education, and Experience
• Bachelor’s degree required in Engineering, Biomedical Engineering, or Life Sciences.
• Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices is required.
• Experience with new product development required.
• Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required.
• Experience in metrology required.
• Strong organizational skills, detail oriented, and the ability to meet changing deadlines on a fast-moving environment.
• Strong documentation capability for protocol and report generation and review.
• Ability to communicate effectively within a technical environment.
• Team player who celebrates winning together
• No travel required.