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Development Quality Engineer-Medical Device

Company: GForce Life Sciences
Location: Saint Paul
Posted on: April 5, 2021

Job Description:

Job Title: Development Quality EngineerDuration: 7+ Months (Contract to Hire)Location: St. Paul, MN (Blended)
The position is not remote - it is a local position. Candidates need to be able to come in at any point. Starting to move to 50% onsite starting end of April
Advanced degree in a technical fieldMedical device experience, specifically with valves and /or implantable devicesExperience working in a broader enterprise/cross-division business unit modelPrior experience working with any or all of the following:ISO 13485 Medical Devices - Quality Management System21 CFR Part 820 FDA Quality System RegulationsISO 14971 Medical Devices - Application of Risk ManagementEUMDRMDSAPGood Manufacturing Practices And Good Documentation Practices
This position will support a new product development project and lead the completion of design control deliverables. The project will be a new development program, following our phase-gate process. Initial work will be related to the Design Input Phase Review, then moving into the Design Selection Phase.Primary work will include test method validation, writing design verification protocols, coordinating sample builds and testing, analyzing test results, writing design verification reports, updating FMEAs and other risk documentation, and maintaining traceability documentation. Key Responsibilities:Core team member - responsible for all DQ deliverables and compliance to the design control requirements.Keep track of deliverables as they are coming due and what is coming down the road weeks and months outAssign deliverables to other engineers --- Lead an extended Quality team meeting with cross-functional team membersGeneral DQ tasks: Risk Management (RMR, dFMEA, uFMEA), Design Verification Testing, Design Validation Testing, Development Test Method Validation. For DV/DVal testing, this includes writing protocols, managing test sample builds, coordinating testing with testing technicians, analyzing results, and writing reports.
Key Requirements: 1) Core team experience2) Problem solving and CAPA experience. Ability to analyze problems and come up with creative solutions. Lead root cause investigation meetings.3) Great communication/leadership skills. Able to work cross-functionally.4) Great documentation writing skills.5) Testing coordination experience6) Protocol development experience.7) Report writing experience. a.Must have good attention to detail b.Able to conduct data analysis and apply statistical technics to data c. Be able to clearly document what was done and justify any deviations to the protocol

Keywords: GForce Life Sciences, St. Paul , Development Quality Engineer-Medical Device, Engineering , Saint Paul, Minnesota

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