Quality Engineer - Complaints - P2

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At 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.

Defined Term 12 months

Purpose Statement of Quality Engineer role in Post Market Quality Assurance:

Provide Quality Engineering support to complaint investigation process, helping to ensure delivery of highest quality of complaint investigations and investigation processes, demonstrating commitment to the Quality Policy (patient safety and product quality) through execution of sound quality practices and the maintenance of an effective quality system.

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.

Requirements - Qualifications & Experience

• HETAC Level 8 qualification 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.

Requisition ID: 616383

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 (NYSE: BSX) 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!