Quality Engineer

Quality Engineer

Location: Cork, Ireland 

Duration: 12 months 

Hours: 39

Imagine your next project with Medical Devices & Diagnostics Global Services, LLC., a company representing more than 60 manufacturing sites and 26,000 employees worldwide. Every day, our teams plan, source, manufacture, and deliver high-quality, cost-effective medical products to customers across the globe. The MD&D Supply Chain supports a wide range of product platforms, new innovations, and delivery systems used in numerous healthcare procedures—including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery, and vision care. Join us in shaping the future of healthcare with products that make a real difference.

Role and responsibilities

The Quality Engineer conducts assignments encompassing complete projects or portions of major projects and determines methods and techniques to be used or adapt standard methods to meet variations. The Quality Engineer utilizes Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle and Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. They utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Business Improvement and Quality Assurance

• Support Continuous Improvement, Quality Assurance and Performance through Lean, Six Sigma, Kaizen,

• PDCA.

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

• Appendix I 100612422 Rev M CONFIDENTIAL use pursuant to Company Procedures 

• Review the effectiveness of continuous improvement tools and techniques; conduct benchmarking to develop more effective methods for improving quality.

• Implement and review effectiveness of Non-Conformance Reporting and CAPA.

Regulatory, Standards and Compliance

• Analyze/review current product and processes are in compliance to ISO 13485, QSR etc., and champion compliance to global regulations such as FDA, MDR, support internal and external audits.

• Conduct periodic line audits for compliance to production controls and review audit findings for Non-Conformance and CAPA.

Product Quality, Control and Disposition

• Support activities in material review board, material identification, segregation, and defect classification.

• Initiate escalation for non-conformance, implement immediate corrective actions and conduct investigation, root cause analysis and bounding of non-conformance as per established process.

Product and Process

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

• 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 Management

• Conduct failure modes cause analysis for products and processes.

• 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.

• 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.

Qualification and Validation

• Conduct, review, and approve IQ, OQ/PQ and CSV for manufacturing and test equipment.

• Establishes suitable measurement systems through the principles of MSA for the collection and analysis of unbiased, reliable, and consistent data e.g., Gauge Repeatability and Reproducibility

• Analyzes and reviews sources of variation in measurement systems, with a view to control of variation.

• Ensures effective quality strategies are created for the validation of test methods, process, and design.

how to succeed

• A minimum of a bachelor’s degree, preferably in Engineering or related technical field.

• 2-4 years’ experience in a related position.

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

• Requires relevant experience working in manufacturing/operations.

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

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, i.e.,

• Measurement System Analysis, SPC, DOEs, Reliability, etc.

Required knowledge, skills, abilities and certifications / licences and affiliations 

• Strong knowledge of statistical software packages is preferred and ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.

• Ability to perform "hands on" troubleshooting and problem solving is preferred, 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 for validation and product/process Risk Management

• (FDA and ISO standards) is preferred.

Benefits

This role offers a very competitive hourly rate. This contract will run for a minimum of 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. 

https://www.jnjmedtech.com/en-US/companies/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. The pay rate for this role will depend on how you are paid. PAYE, Limited & 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”.