Senior Quality Engineer is required by a multinational medical device company based in Cork. The Cork facility is a global centre for product development, manufacturing and supply chain.
The Senior Quality Engineer will be responsible for:
o Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
o Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
o Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
o Supports new product introduction as part of design transfer.
o Approve IQ, OQ, PQ, TMV or Software Validation
The Senior Quality Engineer requires:
o A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
o Experience working in both an FDA and European regulatory environment is preferred.
o This position will require relevant experience working in manufacturing/operations.
o In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
Call Paul at LSC on 021 4777 329 for more information on this new Senior Quality Engineer position or apply directly via this advert.