Transitions - Global Engineering - Quality Assurance Engineer

TN Ireland; Tuam; On-site; EUR 40,000 - 70,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Qualitätsingenieur, der die Qualitätssysteme für globale Engineering-Prozesse verwaltet. In dieser spannenden Rolle sind Sie verantwortlich für die Entwicklung und Einhaltung von Dokumentationen gemäß ISO 13485, die Überwachung der Qualität und Compliance sowie die Unterstützung bei technischen Schulungen. Sie werden Teil eines dynamischen Teams, das sich auf die Verbesserung der Produktqualität konzentriert und einen bedeutenden Einfluss auf die Branche hat. Wenn Sie eine Leidenschaft für Qualität und Compliance haben und in einem internationalen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 3 Jahre relevante Erfahrung in einem regulierten Umfeld (ISO13485/FDA).
• Praktische Erfahrung mit ISO 13485, FDA-Vorschriften und guten Dokumentationspraktiken.

Responsibilities

• Erstellen und Aktualisieren von QMS-Elementen und ISO 13485-Verfahren.
• Technische Eingaben zu Risikoanalysen, Audits und Inspektionen bereitstellen.

Skills

Qualitätsmanagementsystem

ISO 13485

Statistische Datenanalyse

Technische Dokumentation

Interpersonelle Fähigkeiten

Education

Bachelor in Fertigungstechnik

Bachelor in Bio-Medizinischer Technik

Bachelor in Chemie

Job description

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Transitions - Global Engineering - Quality Assurance Engineer, Tuam

Client: EssilorLuxottica

Location: Tuam, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: 9c7a8f74066a

Job Views: 5

Posted: 19.04.2025

Expiry Date: 03.06.2025

Job Description:

WHO WE ARE

We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is uniquely positioned to address the world’s evolving vision needs and the global demand of a growing eyewear industry.

With over 180,000 dedicated employees in 150 countries driving our iconic brands, our people are creative, entrepreneurial and celebrated for their unique perspectives and individuality. Committed to vision, we enable people to “see more and be more” thanks to our innovative designs and lens technologies, exceptional quality and cutting-edge processing methods. Every day we impact the lives of millions by changing the way people see the world.

About Transitions Optical

Transitions Optical has been pioneering and leading the photochromic industry for more than 25 years. We are part of the EssilorLuxottica Group and 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

The Global Engineering team is responsible for accelerating the delivery of emerging technologies through the development of new processes & equipment in Transitions Optical. This is achieved by partnering with R&D to advance new product capability, developing, industrializing and deploying new equipment, executing new product & process industrializations and assisting yield & process improvements.

You will be responsible for the implementation and compliance to relevant quality system regulations and standards for the GE organization. In particular, you will play a key role in developing, deploying, and maintaining GE documentation in compliance with ISO13485. The GE team are seeking someone with a strong process and system mind-set. As part of the GE team in Transitions Optical, you will work in coordination with the overall objectives for EssilorLuxottica.

Key Responsibilities

• Write & update QMS elements and ISO 13485 procedures, processes, forms and templates for Global Engineering.
• Act as the Global Engineering ISO 13485 SME for the Global Validation Lifecycle – including key subsystems such as Equipment Qualification, Risk Management, Process Validation, etc.
• Monitor and maintain the quality and compliance status of associated records, procedures, work instructions, and training materials for the GE department. Liaise with local teams to ensure compliance is maintained.
• Ensure documentation readiness, provide technical input and present as a Global Engineering SME on relevant topics during regulatory inspections.
• Provide technical interpretation and guidance of current EU validation, US FDA, CE Markings & any other relevant standards required by EssilorLuxottica.
• Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Quality Management System (QMS) requirements, including ownership, as relevant.
• Provide Technical input to risk assessments, audits, regulatory inspections and incident investigations.
• Support Global Engineering in the technical writing of Test/ Study / Validation Protocols, Test methods and SOP’s, or reports as needed. Support on training documentation - templates, procedures, with regards to ISO13485 and QMS.
• Deliver training on any existing and new ISO13485 / QMS documentation relevant to the Global Engineering Department.
• Create software documentation after a thorough collaboration with subject matter experts and technical staff.
• Governance of Global Engineering’s CAPAs and deviations, change control.
• Part-take in cross-functional problem-solving teams for troubleshooting and investigations.

Key Requirements

• Bachelor's degree in Manufacturing Engineering, Bio-Medical Engineering, Chemistry, or similar technical field, with a minimum 3 years relevant Quality experience in a regulated environment (ISO13485/FDA).
• Excellent Quality Management System knowledge required. Practical experience with ISO 13485, FDA Quality system regulations, Good manufacturing practices, good documentation practices and other applicable standards.
• Experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques.
• Have technical accuracy in writing user documentation.
• Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
• A dynamic team-player and problem solver who can work effectively on multiple cross-functional teams and projects.
• Excellent organisational skills, attention to detail & systematic approach to work.
• Strong Interpersonal & presentation skills.
• Communicate complex ideas in a concise manner.

Additional Info

• Technical Writer experience.
• Internal Audit Training (ISO13485).
• Industry experience in the ophthalmic/optical sector.
• Knowledge, understanding and implementation of GAMP5 is an advantage.

The role offers opportunities for career & technical development as part of the Transitions Optical structured career development program.

Some international travel might be required – up to 10%.