Senior Quality Engineer - Cork, Ireland

Senior Quality Engineer - Cork, Ireland. 

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Project:

Medical Devices & Diagnostics Global Services, LLC., represents more than 60  manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilisation, clinical laboratory testing, diabetes management, joint replacement surgery and vision care. 

Position Overview  

The Senior Quality Engineer plans conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct the activities of technical support staff and are responsible for the technical development of assigned staff. 

The Senior Quality Engineer will utilise Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product life cycle. The incumbent will also utilise Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilise appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.  This person will support processes in the base business. 

Major Responsibilities & Duties: 

Business Improvements 

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. 
• Review/analyse 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/analyse whether current products and processes (including actions or decisions conducted) are in compliance 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 

• Lead and maintain the Material Review Board.  
• Conduct investigation, bounding, documentation, review and approval of non conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. 
• Accountability and ownership for material identification, material segregation, and classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.  
• Analyze/review the 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. 
• Conduct stakeholder analysis to ensure that customer CTQs are known and  adequately addressed in the control plan 
• Develop measurement systems/capabilities, destructive tests, and non-destructive tests  for manufacturing processes 
• Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. 
• 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 analyses and interpretations as part of process improvements and day-to-day support.  
• Develop, interpret and implement standard and non-standard sampling plans 
• Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, and measurement system analysis.  
• Accountability and ownership for sampling plans of all types including the acceptability of  risk given the product classification, potential defect types, defect frequency, severity, 

Experience Required:

• A minimum of a Bachelor's Degree, preferably in Engineering or a related technical field
• Generally requires 4-6 years of related 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 are required including Measurement System Analysis, SPC, DOEs,  Reliability, etc.  
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.  
• The ability to perform "hands-on" troubleshooting and problem solving is required.  
• The ability to think on the feet and provide sound judgement 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 proven leadership in the areas listed in the Duties and  
• Responsibilities associated with the position. 
• Demonstrated project management and project leadership abilities are required.  
• Continuous Improvement Focus 

In Return:

In return for this role, you will receive a very competitive hourly rate. A minimum 12-month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application. 

If you would like some additional information about the role please contact: 

Tabitha.Crabtree@randstadsourceright.co.uk 

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”.