We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

− Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
− Addresses and corrects product and process complaints.
− Reports on contract manufacturer performance metrics and ensures management reviews.
− Oversees audits of all quality system categories to assess compliance to process excellence standards.
− Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
− Identify and lead cost and technical improvements under the departments’ continuous improvement program.
− Ensuring continuous improvement and understanding of measurement systems used on-site , driving down variance in test methodology.
− Develops site knowledge on manufacturing process knowledge, and monitors inputs and outputs to the processes , and implements and drives corrective actions.
− Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
− Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.
− Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
− Support the implementation of all engineering and plant strategic initiatives.
− Support QA programs in assuring compliance to the pertinent regulation
− Leads and executes upgrades to Quality System
− Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.
− Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, − Supervise others if required

Education & Experience

− Degree Qualified in Science/Engineering
− 18 months relevant experience working in manufacturing/operations.
− Excellent working knowledge of process excellence / QE tools such as pFMEA, SE , statistical analysis, SPC
− CAPA and RCI experience
− Automated process controls experience


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.