Title:  Design Quality Engineer

Design Quality Engineer

 

Company Overview:  

Don’t miss a great opportunity to become part of our team in an exciting, pioneering and growing organisation.

Transitions Optical has been protecting and enhancing vision since 1990 when we were the first company to commercialise plastic photochromic lenses. Through our partnerships with optical industry leaders, we offer solutions that adapt to changing light in the widest selection of designs and materials, including hundreds of lens combinations. We are continuously improving our lenses to enhance their darkness, fade back speed, colour and indoor clarity. Transitions Optical is part of the Essilor Group.

 

Location: Tuam, Co. Galway, Ireland                Reporting Line:     Manager, Innovation Quality & Operational Excellence

 

Job Purpose

 

As Design Quality Engineer your role is to partner with Innovation Project Managers, R&D, GE, Operations & customer teams (based in Ireland and worldwide) on risk identification & control and to serve as the Voice of the Customer during the full end-to-end product innovation cycle in a Regulated environment. You will deploy Stage Gate Methodology to progress product from concept through to feasibility and onto the development & release to production phases.  

 

The fast changing Transitions environment means systems and processes must continually evolve and keep pace with increasing complexity. Transitions is seeking someone with a strong process mind-set and analytical skills to support product definition, product & process risk assessments, execution of test plans, specification development, claims validation and control plan development. You will play a key role interfacing with the Transitions R&D & GE teams along with downstream partners to develop risk analyses and control plans to guarantee product performance & guarantee compliance to product claims and regulatory guidelines.

 

 

Key Responsibilities of the Role

  • 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
  • Risk Analysis - Work with R&D and GE on Technical Risk Analysis and/or FMEA during development and industrialization of new products focussing on the product performance, industrial performances when processing the product along with regulatory compliance.
  • Control plans – In association 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
  • Trouble-shooting focus - Lead problem solving and C.I focus to reduce variation during the development & industrialization phases and as part of the hand-off to the pilot site
  • Hand-shake with pilot sites - Ensure that there is a formal hand-over of quality processes and deliverables to pilot sites & other sites processing Transitions products
  • NPDP optimisation - Support the continuous improvement of the New Product Development Process, e.g. definition of the deliverables for hand-off between Stages while ensuring compliance with ISO 13485
  • Reporting & Documentation - Prepare and present summary documents / presentations of the validation testing results for senior management. Maintain records & documentation that support the One Quality validation process

 

Key Requirements

  • Bachelor degree, or higher, in an engineering or science discipline
  • 5 to 8 years’ experience in a high volume manufacturing facility with strong quality assurance discipline, ideally in a Regulated environment
  • Experience of FMEA, control plan development, Statistical Process Control (SPC) and capability analysis
  • Solves problems through the application of appropriate scientific, experimental, and statistical methods.  Application of Six Sigma and similar methods for reducing variation and improving process knowledge.
  • Intellectually sharp, capable and can conceptualize systems and solutions. Pursues improvement projects with energy, drive and a need to finish. 
  • Proficient in Microsoft Office applications (e.g., Word, PowerPoint, Excel, and Access)
  • Strong presentation skills, utilizing tools to address opportunities for improvement and experience in providing reports and data analysis to a variety of audiences.
  • Customer focus
  • Drive for results
  • Personal learning
  • Interpersonal savvy
  • Managerial courage

 

Desirable

  • APQP or DFSS experience
  • Black Belt in Six Sigma
  • Proficient in the use of JMP statistical software

 

Additional Info

  • Internationally travel required (up to 20%)