Sr Device Quality Engineer I
Biogen IdecFull time Full day
The purpose of this job is to provide Quality Software oversight over design control and risk management activities with Biogen development teams and medical device supplier / testing partners. The Device Quality Engineer III is responsible for approving design control deliverables, assisting investigation and design change closure in a timely manner, supporting review of regulatory product submission filings and support continuous improvement efforts for medical device related processes.
- Lead and manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures.
- Review and approve plans, requirements, protocols and reports generated as part of the software development process. Determine and enforce quality and safety requirements in accordance with company needs and ensure compliance to design control procedures.
- Represent Device Quality on cross-functional teams in support of SDLC activities
- Act as subject matter expert in developing and revising validation documents ensuring compliance with regulatory requirements
- Lead and facilitate Risk Assessment (Desgin (system) FMEA) and Mitigation. Review and approve risk management documents
- Provide guidance and support to device development team in their verification and validation efforts, to ensure compliance.
- Review and approval for quality issues (e.g. deviation, investigations) and technical matters (e.g. design changes, verification and validation) with impact to design control and risk management
- Support regulatory inspections related to Software as Medical Device QMS
- Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed
- Knowledge of IEC 62304, Medical Device Software – Software Life Cycle processes
- Knowledge of GxP and FDA Quality System requirements, 21 CFR 820 and MDR 2017/745
- ISO 13485:2003 (Quality System) requirements
- Excellent communication and collaboration skills
- Education: BA/BS in Life Sciences or Software Engineering with 5 + years in medical device / pharmaceutical industry and/or computerized system validation within a regulated environment
The purpose of this job is to provide Quality Software oversight over design control and risk management activities with Biogen development teams and medical device supplier / testing partners.
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