LSC seeks a Quality Engineer for a global medical device multinational in the Limerick area for a 12 month contract. The Quality Engineer will provide leadership and support to Water Room and Formulations process, and ensures good Quality Engineering practices are in use. Drives continuous improvement through data driven approaches and monitoring of quality systems.
Quality Engineer Job Responsibilities
o Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
o 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).
o Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
o Leads and executes upgrades to Quality System
o New Product Introductions & Product Transfers Lead or actively participate in cross-functional teams
Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.
o Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc).
o Ensure all process developments, NPI etc are managed in accordance with the Quality management system. .
o Maintains and develops risk management lifecycle.
o Ensuring continuous improvement and understanding of measurement systems used on-site , driving down variance in test methodology.
o Develops site knowledge on manufacturing process knowledge, and monitors inputs and outputs to the processes , and implements and drives corrective actions.
The Quality Engineer Requires
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.
o A good understanding and working knowledge of FDA and ISO regulations.
o Knowledge of lean manufacturing .
o Five years experience as Quality Engineer working in a cGMP environment preferably in medical device
Contact Martin today on 0214777329 for a further discussion or respond directly to this advert with your CV.