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QA Engineer II

Company: Foundation Medicine
Location: Somerville
Posted on: May 3, 2021

Job Description:

About the JobThe QA Engineer II works within in the Quality Systems department is a key and critical role at FMI. This role works with various teams within FMI. Within the Quality Systems, team this role partners with all parts of the organization ensuring that the FMI Quality Management System, CAPA's and Non-conformances processes are dynamic, effective, and compliant, creating a competitive advantage for FMI. This position supports the planning and work of multiple projects and scrum teams with a big picture mindset and is accountable for achieving all related business goals.KeyResponsibilitiesExtensive experience in supporting, identifying and improving current Quality Management SystemProvides guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure complianceConduct periodic reviews to assess QMS adherence to domestic and international Good Manufacturing Practice (GMP) regulations, current GMPs, and company policies.Identify and guide the organization on strategy and implementation of continuous improvement and harmonization of the quality system across all sites.Works independently and directly with all departments to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.Effectively collaborate with a fully integrated team to facilitate the completion of documents.Maintain Quality Management Systems for functional area including Design Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non-Conforming Material Reports.Proficient in conducting root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.Responsible for developing, measuring and monitoring key KPI'sTravel up to 15% of the timeOther duties as assigned.QualificationsBasic QualificationsBachelor's Degree or equivalent years of experience Bachelor's Degree with 5+ years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry; Or 10+ years with equivalent experience.Master's Degree with 3+ years of experiencePreferred QualificationsDegree in the Sciences, Engineering or Business-related fieldExperience with IVD, or Medical Device Quality SystemsAdvanced knowledge of standards and regulations pertaining to the IVD and/or Medical Device industry, both domestic and international and not limited to FDA QSR 820, ISO13485, ISO15189, CAP/CLIA, & IVD/IVDRExtensive knowledge of Good Manufacturing PracticesProficiency in CAPA and Root Cause InvestigationsProficiency in Microsoft Office, Word, Excel, Project and PowerPointDemonstrated ability to lead, communicate, interact and influence effectively quality system changesAbility to work in a fast-paced environment with strong attention to detailStrong troubleshooting and problem solving skillsExcellent communication skills and proven ability to work effectively as a member of a multidisciplinary teamUnderstanding of HIPAA and importance of privacy of patient dataCommitment to FMI values: patients, innovation, collaboration, and passion#LI-Remote[Cambridge, Massachusetts, United States]SDL2017

Keywords: Foundation Medicine, Somerville , QA Engineer II, Other , Somerville, Massachusetts

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