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
Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
Professional
All Job Posting Locations:
Ringaskiddy, Cork, Ireland
Job Description
About Orthopaedics
Fuelled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at
As a Quality Operations Team Lead
The Quality Operations Team Lead devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. The Quality Operations Team Lead is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods. The Quality Operations Team Lead will utilize Quality 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 and supervise, lead and mentor other engineers and technicians.
The Responsibilities And The Impact YOU Will Have
* 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, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
* Compliance/Regulatory.
* Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
* 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.
* Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians).
* Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate
Risk Mitigation
* Document, justify, review, or analyse 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.
Ehs&s
* Actively promote a safety culture.
* Management of tasks and action plans relating to corrective and preventative actions assigned to the team.
We would love to hear from YOU, if you have the following essential requirements:
* Degree qualified in a relevant Engineering/Science discipline, and/or 5+ years relevant experience in the Medical Device industry or medical field.
* Demonstrated leadership skills and the ability to make effective decisions.
* Experience with a proven track record of implementing appropriate risk mitigation.
* Good technical understanding of manufacturing equipment and processes is required.
* Strong mentoring, coaching and leadership skills are required.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Required Skills
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)