Senior Quality Engineer: Med Devices, NPI & CAPA Leader

Johnson & Johnson Co.; 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

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