Design Assurance Specialist
|Contact Name:||Larry O’Leary|
Our client a innovative medical devices manufacturer based in Galway, now seeks a Design Assurance Specialist to manage the transition of products from R&D through to commercial launch, exercising risk management associated with the design, use and manufacture.
The successful candidate with work with product development and related sustaining engineering activities, across a number of product areas.
Responsibilities of Design Assurance Specialist:
Supports product lines post commercial launch.
Use validation techniques, risk management, statistical techniques and associated regulatory requirements as part of work.
Provide input to the Quality review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
Requirements for Design Assurance Specialist:
Degree in Chemical, Engineering, Sciences or equivalent qualification.
4+ years experience in resolving quality assurance issues, in line with a Quality Management System.
Strong experience in using problem solving tools, preferably six sigma or similar.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Please contact; Larry on +353 1 2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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Key words; R&D, Process Development, Quality, Manufacturing, Commercial Launch, Design Engineering, Medical Devices, Pharmaceutical, New Product Introduction, Galway, Clare, Connaught.