Description
Johnson & Johnson Innovative Medicine is currently seeking a Quality Engineer to join our operations team located in Cork, Ireland.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Are you a detail-oriented professional passionate about ensuring top-notch quality in products and processes? Do you possess a bachelor’s degree in engineering or a related field? Are you skilled in conducting root cause analysis and implementing corrective actions? Then we have a position for you!
What You Will Be Doing
The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally.
The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize 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 utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
What Impact You Will Also Have
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 comply with 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 non-conformances, 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.
Strategic
* Ensures effective quality strategies are created for the validation of test methods, process and design.
Qualifications
We would love to hear from YOU if you have the following requirements:
* A minimum of a bachelor’s degree, preferably in Engineering or related technical field.
* 2-4 years’ experience as a QE or 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 is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
* 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.
* Demonstrated project management and project leadership abilities are preferred.
* This position may require up to 10% travel.
What’s in it for YOU?
This is an opportunity to work with a ground-breaking medical device operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
* An opportunity to be part of a global market leader.
* A dynamic and inspiring working environment.
* Opportunities to work on challenging projects and assignments.
* Possibilities for further personal and professional development/education.
* Excellent Benefits (Pension, Healthcare, Bonus, among others).
What type of mark will YOU make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"!
For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.
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