J&J Family of Companies Quality Engineer in Limerick, Ireland
Johnson & Johnson Vision Care, part of the Johnson & Johnson Family of companies currently have an opportunity for a Senior Quality Engineer to join the Quality Department at our manufacturing facility in Limerick.
You will provide leadership and support to root cause investigation activities, and ensures good Quality Engineering practices are used in investigations. Drives continuous improvement through data driven approaches and monitoring of quality systems.
Main areas of responsibility:
− You will provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
− You will utilizes multifaceted industry and process excellence standards on an experienced level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
− You will addresses and corrects product and process complaints.
− You will report on contract manufacturer performance metrics and ensures management reviews.
− You will handle 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
− Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
− 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
− Leads and executes upgrades to Quality System
− You will support QA programs in assuring compliance to the pertinent regulation
− Identify and lead cost and technical improvements under the departments’ continuous improvement program.
− Provide key inputs and leadership into transformational process developments.
− Project Management - provide timely and accurate reporting on project activities.
− New Product Introductions & Product Transfers
− Lead or actively participate in multi-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.
− Actively collaborating with multi-functional team members, always practicing good collaboration in support of day to day operating requirements.
− Demonstrate strong leadership and a clear identifiable work ethos within the team.
− Develop and maintain a Credo & Behavioural Standards based culture within the group.
− Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc).
− Ensure all process developments, NPI etc are run in accordance with the Quality management system.
− Implementation of safety/environmental requirements on purchase of all new equipment.
− Work with team leader to develop and implement strategic engineering Goals & Objectives.
− Support the implementation of all engineering and plant strategic initiatives.
− All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform
− Maintains and develops risk management lifecycle.
− 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.
− Sustains and advocates Credo based standards in all aspects of work.
Education and Experience Required for Role
− Degree Qualified with 3-5 years relevant experience in Medical Devices/Pharmaceutical Industry
− Ability to work on own initiative
− Flexible work ethic
− Attention to detail
− Excellent working knowledge of process excellence / QE tools such as pFMEA, SE , statistical analysis, SPC
− CAPA and RCI experience
− Excellent IT skill eg, experience in minitab, excel reports
− Risk management experience
− Automated process controls experience
− Good presentation skills
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Johnson & Johnson Vision Care (Ireland) Limited (8182)