Sr Quality Engineer – Medical Device

Job Title: Sr Quality Engineer – Medical Device Job Location: Danvers, Massachusetts (Fully Onsite) Type: W2 Contract Job Description: Technical skills that are required for the role: Medical Device Design & Development Risk Management: dFMEA, pFMEA, Statistical analysis Technical Writing: IQs, PQs, TMVs Years’ Experience Required: 5 years. Education Required: Bachelor’s Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality Responsibilities Include: Provide Quality Engineering support for commercial medical device products. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Present technical data to groups within and outside the organization. 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. Nice to Have: Preferred Qualifications SAP QM or SPC Software Experience Effective verbal and written communication, analytical, influencing and interpersonal skills Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 Demonstrated working knowledge of process validation, statistical methods, risk management. Seniority level

Mid-Senior level Employment type

Contract Job function

Engineering, Design, and Manufacturing Industries: Biotechnology Research, Medical Equipment Manufacturing, and Medical Practices

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