Senior Quality Engineer

Johnson & Johnson; Limerick; On-site; EUR 34,000 - 62,000; Full time

Job summary

Johnson & Johnson Vision is seeking a Senior Quality Engineer to support complex product teams in designing and auditing quality systems, ensuring GMP and ISO compliance, and driving continuous improvement across manufacturing processes. You will lead cross-functional teams on new product introductions and product transfers, manage CAPA programs, and mentor staff to uphold Credo-based standards.

The role involves interfacing with engineering, operations and information management, and requires

Qualifications

• Degree qualified with science or engineering degree.
• 3-5 years relevant experience in Medical Devices/Pharmaceutical Industry.
• Excellent working knowledge of process excellence / QE tools such as pFMEA, SE, statistical analysis, SPC.
• Excellent IT skills, e.g., experience in Minitab and Excel reports.
• CAPA and RCI experience.
• Automated process controls experience.
• Supervision of others.

Responsibilities

• Provides complex product team support for quality system design and audit, compliance assessment, and support of steady state manufacturing processes.
• 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.
• 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, practicing good teamwork for 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, NCRs, CAPAs, 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 Environmental and Health & Safety effects of the work.
• 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.

Job description

Roles and Responsibilities

• 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

How to Succeed

Essential Requirement for Quality Engineer

• Degree Qualified with science or Engineering Degree

Essential Requirements for Senior Quality Engineer

• Degree Qualified with science or Engineering Degree with 3-5 years relevant experience in Medical Devices/ Pharmaceuical Industry
• Excellent working knowledge of process excellence / QE tools such as pFMEA , SE , statistical analysis , SPC
• Excellent IT skill eg , experience in minitab , excel reports
• CAPA and RCI experience
• Automated process controls experience
• Supervision of others

This role offers a very competitive hourly rate. This contract will run for 12 months.

about Johnson & Johnson Vision

Johnson & Johnson Vision brings together cutting-edge insights, science, technology and people. We partner with eye care professionals and help more people around the world preserve and restore sight. Our portfolio includes the best selling contact lens brand in the world, ACUVUE®, plus consumer eye health solutions, dry eye treatments, refractive (Lasik) and cataract products. Contribute to the next healthcare breakthrough, create a world connected by SIGHT™ with your next project at Johnson & Johnson Vision.

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.