Boston Scientific Quality Engineer II 

Ireland, Galway 

638996914

Key Responsibilities:

• Ownership of the execution of complaint approvals within the BSC Global Complaints Management System which includes a comprehensive review of Complaint Investigations to ensure they meet regulatory and BSC requirements.
• Ownership of the execution of complaint investigations within the BSC Global Complaints Management System which includes execution of insightful laboratory testing on returned complaint devices, where required.
• Complaint event root cause analysis and determining investigation pathways and any actions to be taken.
• Using data analytics tools to monitor product performance and investigation process performance.
• Preparation and provision of complaint trend data and sharing of data and trend analysis at review forums.
• Drives continuous improvement initiatives to investigation methodology and associated processes and lead applicable projects of improvement.
• Make decisions and determine escalation pathways, as well as demonstrating ability to work on one’s own initiative and with minimum supervision is required.
• Understands and complies with all the regulations governing the quality systems.
• Development and maintenance of collaboratively relationships within the Galway investigation team, and with other investigation and complaint management centre teams across the global Post Market Quality Assurance function.
• Development and maintenance of partnerships with Quality Operations, Design Assurance, Field Support and R&D for the execution of insightful investigations and to support product performance improvements.

Education & Experience:

• Level 8 Bachelors Degree in a STEM subject with a min. of 2-3 years relevant work experience.
• Demonstration of problem solving, process improvement and/or project management skillsets and application.
• Demonstration of taking initiative to drive improvement and change.
• Knowledge on product design, manufacture, functionality and/or clinical use environment. Experience of product design or manufacturing would be an advantage.
• Good technical capabilities, communication skills and organisation skills. Ability to analyse data to gain insights and to share information effectively.
• Proven ability to work well with teams but also with minimum supervision.
• Experience of Angiographic image review experience would be an advantage.
• Hepatitis B Vaccinations course required to work with returned decontaminated product.

To search and apply for open positions, visit: