Senior Quality Engineer

We are seeking a Sr Quality Engineer for a very important client. A Day in the LifeIn this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives. This is an onsite role at the Danvers, MA location.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.Must Have: Minimum Qualifications· Bachelor's Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR· Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.Nice to Have: Preferred Qualificationso Medical Deviceo Master's degreeo Manufacturing Experienceo Green Belt Six Sigma/DRM Training/Certificationo ASQ-CQE, CQA, CBA or equivalent certificationso SAP QM or SPC Software Experienceo Effective verbal and written communication, analytical, influencing and interpersonal skillso 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 13485:2016o Demonstrated working knowledge of process validation, statistical methods, risk managementTop 3 technical skills that are required for the role:Medical Device Design & DevelopmentRisk Management: dFMEA, pFMEA, Statistical analysisTechnical Writing: IQs, PQs, TMVsEducation Required:· Bachelor's Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR· Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or QualityYears' Experience Required: 5 yearsNice To Have• Green Belt Six Sigma/DRM Training/Certification • ASQ-CQE, CQA, CBA or equivalent certifications • 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

Created: 2025-10-02