Johnson & Johnson Careers
Senior Quality Engineer
Requisition ID: 1805668190W
Position Title: Senior Quality Engineer
Report to: Business Unit Quality Manager
Location: Vision Care, Limerick
Johnson & Johnson Vision Care Ireland is located in Limerick and produces the Acuvue range of contact lenses which is the leading contact lens product in the world. Our Limerick site uses the most advanced technology in the industry and we now employ over 900 people directly. Using our highly automated production process, we produce daily disposable contact lenses while utilizing state of the art technologies such as injection moulding, robotics, vision systems and sterilisation systems.
Johnson & Johnson Vision Care Ireland was established in 1995 in the National Technology Park close to the University of Limerick. The facility was originally fitted with six advanced production lines to manufacture one daily disposable contact lens for the European and Japanese markets. Since then we have expanded a number of times and now have over 31 production lines manufacturing one-day, fortnightly, monthly and colour contact lenses which are shipped worldwide.
Each year, we have increased output because of the increase demand for our Acuvue lenses throughout the world Continued expansion of our product lines and extensive engineering and retrofit projects ensure that this growth is sustained well into the future.
Provides 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:
· Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
· 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
· 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
· 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 cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.
· Actively interfacing with cross-functional team members, always practicing good team work 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 managed 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.
· Supervise others if required
· Responsible for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations, FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211 as applicable, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company's products including medical devices and combination products
Education & Experience
· 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
· Supervision of others
Johnson & Johnson Vision Care (Ireland) Limited (8182)