Senior Design Assurance Manager
4 weeks ago
My client, a global leader in the life science sector, seeks to hire a Senior Design Assurance Manager on a permanent basis.Â
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Responsibilities
·        Develop & manage execution of the Design Controls process.
·        Provide Design Assurance oversight within the NPI area.
·        Manage resources to support product launches.
·        Coordinate regular design reviews.
·        Ensure product/process/label and test method designs and documentation comply with regulatory requirements.
·        Monitor post-market surveillance trends.
·        Collaborate with R&D and Design Quality teams to ensure successful new product launches and design transfer process.
·        Represent design quality with external regulatory authorities and respond to queries. Â
·        Collaborate with Regulatory Affairs & R&D to establish appropriate filing.
·        Collaborate with R&D on Product Test Methods.
·        Work with R&D on product scale-up and transfer to commercial manufacture.
·        Develop design assurance processes, systems, and staff.
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Requirements
·        Degree in Engineering/Science/ Life Sciences.
·        5 years minimum experience in QA/R&d or other technical leadership role in a regulated environment
·        Extensive knowledge of Medical Devices and experience in a fast-moving R&D environment.
·        Track record of delivering successful NPI programs
·        Track record of delivering successful CI programs.
·        Experience managing in an environment with changing priorities
·        Experience managing a design assurance team essential.
If interested please send your CV to emer.long@cpl.ie
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