Staff Design Quality Engineer

Staff Icons

United States

United States

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Position Summary The Staff Design Quality Engineer is primarily responsible for leading the Design Controls planning, establishing and maintaining the Design history file (DHF), ensuring compliance with all applicable regulations. The position will work in collaboration with the Assay/IVD/CDx Development, Laboratory Operations, Regulatory Affairs, project/program management, and other cross-functional teams throughout the product lifecycle. Requires strong track record of working with the cross functional teams. The role will support management reviews and interna/external audits related to Design Controls and Risk Management. Job Responsibilities Responsible for creating the Design and Development Plan (DDP) for the new development projects, updating the DDP throughout the lifecycle of the product. Create and maintain risk management file with support from cross-functional teams including risk management plan/report, hazard analysis, dFMEA, uFMEA. Provide mentorship, guidance and training to the product development teams new to design controls and risk management processes. Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications. Manage deviation and issues for the verification and validation activities. Support design reviews and design transfer activities including process validations, pFMEA and DMR. Support design changes and post market activities, for example deviations and corrective and preventive actions (CAPA) to ensure product safety Perform risk assessments for the regulatory submissions. Support the implementation of eQMS tools for design controls and risk management (eDHF). Support Management reviews and internal/external audits as a subject matter expert. Participate in process improvement initiatives as necessary, performing gap analysis Perform complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management. Required Qualifications Bachelor's degree in engineering, scientific or related field. Minimum 6+ years of hands-on experience, or relevant comparable background. Hands-on experience with ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971 IVDR. Technical expertise and understanding of IVD assays and data analysis tools. Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems. Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file. Preferred Qualifications ISO 15189, CAP/CLIA and GCP/GCLP and IEC 62366 preferred. Adaptable to fast-paced, dynamic work environment with shifting demands. Experience working with eQMS. Experience in supporting regulatory inspections. Physical Demands Employee may be required to lift routine office supplies and use standard office equipment. Ability to sit for extended periods of time. Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment. Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other This position requires periodic travel and some evenings, weekends and/or holidays. Job may require after-hours response to emergency issues. At times may be required to work weekends/holidays.

United States

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English

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