Quality Engineer I

Clonmel, Co Tipperary
Permanent
Full-time

1 day ago

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.Advancing possibilities for a brighter tomorrowWe are seeking a Quality Engineer P1 on a Defined Term (12 month) basis to join our team.Job Purpose:This dynamic Quality Engineering role supports all aspects of the LithoVue production line in our Clonmel facility. The position offers a significant opportunity to gain in-depth knowledge of the Boston Scientific Quality System, with a focus on production and process controls and CAPA. You will play a key role in ensuring product quality, supporting manufacturing operations, and driving continuous improvement initiatives in a regulated environment.Your responsibilities will include:

Gain a working knowledge of urology scopes manufacturing processes and support the transfer, stabilization, and setup of production lines in Clonmel
Execute and support process qualification and validation activities, including PQs, TMVs, Gage R&R, capability studies, DOEs, and control plans in line with established quality engineering standards
Implement and sustain process monitoring, inspection activities, and nonconforming material controls to ensure compliance with corporate quality systems and regulatory requirements
Investigate manufacturing quality issues, including scrap, nonconformances, and complaints, using structured problem-solving methodologies to determine root cause and drive effective CAPA through eCAPA and Engineering Essentials
Provide clear technical communication to cross-functional stakeholders and support site readiness and execution of internal, customer, and regulatory audits
Apply structured problem-solving techniques to resolve quality and manufacturing issues of moderate complexity, using sound judgment and understanding of manufacturing impact

Education & Experience:

Level 8 Honours bachelor's degree in engineering, quality, or a related scientific discipline
Strong communication skills with the ability to apply sound technical judgment and promote Quality at Source
Experience in a regulated or medical device manufacturing environment
Knowledge of MES systems, scopes manufacturing processes, process monitoring, and product disposition

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!To search and apply for open positions, visit:At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email ..

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