- Entry level
- No Education
- Salary to negotiate
Position Description(s) Title: Quality Engineer/ Senior Quality Engineer (Shift based)
Position Title(s) :
Senior Quality Engineer
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
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
Desirable (for both roles):
− Risk management experience
− Automated process controls experience
− Good presentation skills
− Supervision of others
Johnson & Johnson Vision Care (Ireland) Limited (8182)
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.