Our client a innovative medical devices manufacturer based in Galway, now seeks a Quality Specialist to manage the transition of products from R&D through to commercial launch, exercising risk management associated with the design, use and manufacture.
Scope of role: product development and related sustaining engineering activities, across a number of product areas.
This hire will require strong communication skills with ability to work in cross-functional teams, interfacing with R&D, Clinical, Marketing, Process Development and Manufacturing in a project core team environment providing technical and Quality systems input to the team.
Responsibilities of R&D Quality 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 R&D Quality 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 / email@example.com
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
Key words; R&D, Process Development, Quality, Manufacturing, Commercial Launch, Design Engineering, Medical Devices, Pharmaceutical, New Product Introduction, Galway, Clare, Connaught.