About
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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
Boston Scientific is proud to be an equal opportunity and affirmative action employer. xcfaprz 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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Languages
- English
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