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Principal Compliance Engineer

Company: AgreeYa Solutions
Location: thousand oaks
Posted on: May 3, 2021

Job Description:

Position - Principle Compliance EngineerLocation - Thousand Oaks, CAContract - 6+ MonthsDetails:These 2 positions will start out remote due to COVID but will be required to be onsite once we're back to the office.About the position:Senior level position that is responsible for the quality oversight of design control, process controls, and risk management activities for combination products.This individual will work closely with the device development teams and medical device suppliers and testing partners during the device design/development phases with supportive responsibilities throughout the device lifecycle.Key components of the job function include:Lead Quality Engineering guidance and oversight for medical device and combination products, all phases of design control, risk management, human factor/usability engineering, process development, as well as lifecycle management during design changes.Work with the device combination team to define critical to quality characteristics for device components and finished devices.Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix,protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.Support Project Team and strategy for developing and implementing changes through author.

Keywords: AgreeYa Solutions, Thousand Oaks , Principal Compliance Engineer, Other , thousand oaks, California

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