Design Assurance Engineer
Our client, a Medtech company based in Galway, now seeks a Design Assurance Engineer to work in R&D and assist in the scale up and commercialization of product, including; new product design, development, introduction validation and improvement of medical products from R&D and assist in the scale up and commercialization of product.
The successful candidate will be working on highly visible projects in high-pressure situations with significant opportunity to work on strategic projects, with new product development, risk management, sustaining management, post marketing surveillance, clinical teams and complaint management / customers.
Responsibilities of Design Assurance Engineer:
Lead Quality review at defined design reviews, project design plans, risk management, Support risk management activities
Lead evaluation of new products, assuring the safety and efficacy of the devices
Support design verification and shelf life protocols / reports
Lead qualification and validation activities
Exercise knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
Ensure adherence to Quality System and Design Control requirements
Drive root cause investigations; drive problem solving efforts for quality issues
manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
Present information to Regulatory Affairs to minimize Regulatory Agency questions
Manage customer complaint analysis and post market surveillance activities
Requirements for Design Assurance Engineer:
Honours Bachelor's Degree or higher in Engineering, Science or a related discipline.
3+ years' relevant experience in resolving quality assurance issues, in line with a Quality Management System.
Track record in working independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Must have good written & oral communication skills and the ability to communicate with cross functional people.
Please contact on Larry on 01-2302400 / 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 / www.meddevicejobs.ie
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