LSC seeks a Quality Engineer for a global medical device multinational in the Cork area for a 12 month contract.
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 Conduct benchmarking to develop more effective methods for improving quality.
o Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
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 Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
o Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
o Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
o 5 yrs experience in a regulated environment.
o SIX SIGMA – Certification
o Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
o Experience of the design and qualification documentation standards to current FDA expectations
o Knowledge of statistical packages and Microsoft Office systems required.
o Proven ability to review and critique Quality Critical technical documents.
Contact Ruth today on 0214777329 for a further discussion or respond directly to this advert with your CV.