Job Information
EssilorLuxottica Transitions - Senior Design Quality Engineer in Tuam, Ireland
Transitions - Senior Design Quality Engineer
Date: Jun 27, 2024
Brand: Transitions
Location:
Tuam, IE
Company Overview:
Over 25 years of successful Research and Development has positioned Transitions Optical as the market leader in the photochromic industry. As part of the EssilorLuxottica Group, we transform lives by enabling people to engage with the world and to fully express themselves.
In Transitions Optical, we are all about living Seamlessly . That’s what our products enable, whether it’s changing from light to dark without breaking stride. Or the freedom of using a product that’s so perfect for you that you forget you’re even wearing it. It’s what our company does. Whether that’s through innovating in both style and technology, together, seamlessly. Or through marrying the start-up spirit with the heavyweight power of the global leader.
There are people who can see the future. There are people who can build it. And there are people who can do both. We’re looking for the latter.
Job Purpose
This is a key role within our Global Quality team but also within our broader integrated Innovation engine. The fast-changing environment within Transitions Optical means that our innovation processes and the supporting organisational capabilities must evolve to keep pace with increasing levels of complexity and customer expectations.
The Innovation Quality team is central to our integrated innovation process and the team partners very closely with all functions in our product life-cycle from R&D, Global Engineering, PMO through to Operations and supports our Commercial and Marketing teams.
As Senior Design Quality engineer, you will work primarily on New Product Development projects, collaborating with all functions on all aspects of our integrated innovation process including – supporting introduction of new products and processes following stage-gate methodology, risk identification & control and serve as the Voice of the Customer during the full end-to-end product innovation cycle - from concept through feasibility, development & commercialisation.
Transitions Optical Ltd is accredited to ISO9001:2015 and ISO13485:2016.
As this role involves global cross-functional teams, contributing to the effective design and development of products & processes in the field of medical devices, this may also suit a senior candidate looking to migrate from a R&D / Engineering role with relevant experiences.
Key Responsibilities
Product Definition - Work with R&D, Marketing & Commercial teams on the full end-to-end product definition.
Quality Design Control Deliverables - Participates in project teams to review and develop clear and concise user requirements, verification and validation studies, risk analysis, test plans, control plans and product specifications in line with ISO 13485 & regulatory requirements.
Risk Analysis – Lead / facilitate Risk Management activities during development and industrialisation of new products in accordance with ISO14971.
Control plans - In collaboration with GE, identify and define critical to quality (CTQ) product characteristics.
Downstream Validations - Work with downstream partners on validations to ensure controls in place to deliver customer and regulatory requirements.
Validate New Raw Material Suppliers - Support the definition & control of process inputs including supplier & raw material controls, QA testing & process control plans.
Analytical Test Methods - Work with R&D to develop and validate analytical methods and specifications to qualify products in line with customer requirements and product claims.
Continuous Improvement Focus – Lead / support problem solving and continuous improvement to reduce variation during the development, industrialization & transfer into production.
Reporting & Documentation - Prepare and present summary documents / presentations of the validation testing results for senior management.
Innovation Quality Processes – Provide project guidance on compliance to our stage gate methodologies / requirements and support the continuous improvement & evolution of our Innovation Quality processes that underpin an effective QMS in line with ISO13485 requirements.
Key Requirements
Bachelor degree, or higher, in an engineering or science discipline.
5 to 8 years’ experience in new product development and/or manufacturing with strong quality assurance discipline, ideally in a regulated environment. FDA, EU MDR & ISO 13485 / ISO 14971 knowledge a distinct advantage.
Experience in Risk Management (e.g. FMEA), Validations, SPC and Capability Analysis.
Continuous improvement / problem solving experience through the application of appropriate scientific, experimental and statistical methods.
The ability to prioritise tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
Attention to detail and accuracy is essential.
Success Factor
Customer focus
Drive for results
Personal learning
Interpersonal savvy
Managerial courage
Communication
Desirable
Black or Green Belt in Six Sigma.
Proficient in the use of statistical software (e.g. JMP or Minitab)
Additional Information
- International travel may be required.
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Job Segment: Medical Device, Six Sigma, PLM, Healthcare, Management