Job Description
We urgently seek an R&D Quality Specialist to manage and eliminate any risks associated with the design, use and manufacture of medical device products, from development into commercial manufacture.
This successful candidate will interface with R&D, Clinical Marketing, Process Development and Manufacturing in a project core team environment providing technical and Quality systems input to the team.
This role is with a growing healthcare manufacturing company based in Galway.
Responsibilities of R&D Quality Specialist
Provides 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.
Be familiar with requirements and procedures that govern the Product Development Process and Design Control requirements.
Use validation techniques, risk management, statistical techniques and associated regulatory requirements as part of work
Supports product lines post commercial launch.
Requirements for R&D Quality Specialist:
Degree in Chemical, Engineering, Sciences or equivalent qualification.
3+ 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 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie/
Key words; R&D, Process Development, NPD, Quality, Manufacturing, Commercial Launch, Design Engineering, Medical Devices, Pharmaceutical, New Product Introduction, Galway, Clare, Connaught.