Quality System Engineer (Software as Medical Device) - Remote

Employer
Elsevier
Location
Washington, DC
Posted
Dec 05, 2022
Closes
Dec 08, 2022
Ref
724434505
Industry
Engineering
Hours
Full Time
A$ A' "A' ?Quality System Engineer (Software as Medical Device) - RemoteResponsibilitiesServing as quality liaison to design teams to ensure that products are tested against their intended use. Testing is documented properly and auditable; that proper medical device design controls are followed.Supporting new product development and design change activities ensuring execution of the Quality Plan, Product Risk Management activities.Working closely with Technology to develop and implement appropriate risk management, qualification, verification, and validation testing plans.Providing quality system guidance and participates where appropriate in Feasibility, Development, Design Verification. Supporting Design Validation, Design Transfer and Commercialization reviews and activities.Performing even-handed technical assessment on product quality performance and post-market product quality analysis.Participating in quality system audits in accordance with documented procedures.RequirementsExperience in medical device quality engineering, working with Software as a Medical Device (SaMD).Have familiarity with quality system regulations or experience interacting with regulatory teams, etc.Have FDA/ISO/TS quality system knowledge and experience.Experience in working with technology teams and/or understanding of software architecture.Experience with Agile software development.Have familiarity with Medical Device Regulations (FDA 21 CFR Part 820, MDD/MDR, MDSAP, etc.) and related ISO/IEC standards (ISO 13485, IEC 62304, ISO 14971, MDDS, TIRs etc.).

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