Quality Operations Engineer

Quality Operations Engineer

Location: Cork, Ireland

Duration: 12 month contract

Hours: Full time on site, 39 hours per week

Quality Operations Engineer Reports to: Quality Operations Team Lead

The Quality Engineer leads production projects or segments of larger manufacturing initiatives, selecting or adapting methods and techniques to support day‑to‑day operations and continuous production needs. They coordinate cross‑functional and supplier activities to ensure smooth production transfers and launches, and use Quality Engineering tools (e.g., SPC, FMEA, DOE) to maintain and improve manufacturing processes throughout the product lifecycle. Applying root‑cause problem solving, CAPA, and risk management, they prevent unplanned downtime and failure modes, improve yield and process capability, and ensure compliance with quality and business targets. They also provide ongoing production support, troubleshooting, and process optimization for core manufacturing operations.

roles and responsibilities.

The Quality Operations Engineer will support quality improvement initiatives, ensure regulatory compliance, and partner with cross-functional teams for new product introductions and process controls. This will involve:

Business Improvements

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

• Conduct benchmarking to develop more effective methods for improving quality

• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

• Compliance/Regulatory Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.

• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

• Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

New Product/Process Introduction

• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.

• Supports new product introduction as part of design transfer.

Product Quality, Control & Disposition and Performance Standards

• Supports activities related to the Material Review Board.

• Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

Product/Process Qualification

• Approve IQ, OQ, PQ, TMV or Software Validation

Production/Process Controls including Control Plans

• Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.

• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

• Develop, interpret and implement standard and non-standard sampling plans

• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.

• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Risk Mitigation

• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

how to succeed.

You will have a minimum of a bachelor’s degree in Engineering or a related technical field, with at least 1 year of experience and a strong background in manufacturing operations and risk management. You will also bring:

• A minimum of a bachelor’s degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience preferred. Minimum 1 Year experience.

• Experience working in both an FDA and European regulatory environment is preferred.

• This position will require relevant experience working in manufacturing/operations.

• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

• Experience with a proven track record of implementing appropriate risk mitigation.

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.

• The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.

• Good technical understanding of manufacturing equipment and processes is required.

• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.

• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.

• Demonstrated project management and project leadership abilities are preferred.

• This position may require up to 10% travel

benefits.

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

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about DePuy Synthes

DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS™ Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes.

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.

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”.