Senior Design Assurance Manager

4 weeks ago


County Galway, Ireland Cpl Full time

My client, a global leader in the life science sector, seeks to hire a Senior Design Assurance Manager on a permanent basis. 

 

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.  

·        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.

 

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

 

#LI-EL2

#CplEmerLong 



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