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Senior Design Quality Engineer

Company: Exact Sciences
Location: Somerville
Posted on: May 3, 2021

Job Description:

Summaryof MajorResponsibilitiesThe Senior Design Quality Engineer will lead a variety of activities supporting In Vitro Diagnostic (IVD) new product development and risk management and will be responsible for quality evaluation and design control within the product development process. This position will work cross-functionally to support product design and/or maintenance of product design changes and ensure that the appropriate development controls are in place, consistent with business objectives and regulatory requirements.Essential Duties andResponsibilitiesInclude but are not limited to the following:Work with cross-functional teams to participate in product development through all of its phases, including verification and validation activities, and ensure that the resulting work products are in compliance with applicable regulations and standards. Represent Quality on product development and product or process improvement projects, and participate in product life cycle phase reviews. Guide continuous improvement efforts in the design control process, design validation and verification master plans/project plans and standard operating procedures relating to the product development process. Guide continuous improvement efforts for product test method validation, and assist in the creation of test method protocols. Lead product risk management activities including system hazard analyses, product risk assessments, human factors studies and maintenance of product risk management files. Assure product labeling is accurate and compliant, including the Instructions for Use. Support business objectives relating to product software design validation efforts. Establish quality standards for products, processes and procedures. Support registrar audits, including quality and process improvement projects. Perform other related duties as assigned by management. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Regular and reliable attendance. #LI-AZ1QualificationsMinimumQualificationsBachelor's degree in an engineering or computer science field, or related field with the equivalent combination of education and experience.5 or more years' experience in a GMP and/or ISO13485 Working knowledge of ISO149713 or more years' experience in a direct Quality Assurance or Engineering role in a product development core team following FDA/ISO design control requirements.Knowledge of NextGen Sequencing technology and bioinformatics.Demonstrated aptitude in the application of statistical analysis and tools.Excellent interpersonal skills with the ability to collaborate closely with Development staff at varying levels to drive compliance and operational excellence.Proven ability to lead and work effectively with and through multi-functional teams to achieve results.Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Authorization to work in the United States without sponsorship.Preferred QualificationsMaster's degree in Engineering, Science or Math-related fieldExperience with Project Management principles and practiceDemonstrated experience in Design for Six Sigma (DFSS) techniquesPhysicalRequirementsAbility to use computers daily in an interactive manner for extended periods of time. Ability to sit for an extended period of time. Ability to frequently and accurately communicate with employees in person, via the telephone or by email We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.JobSummaryReq No.: 2021-7949Category: Quality Assurance & Regulatory AffairsType: Regular Full-TimeSDL2017

Keywords: Exact Sciences, Somerville , Senior Design Quality Engineer, Other , Somerville, Massachusetts

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