Senior Quality Specialist Ireland & Nordics

Senior Quality Specialist - UK, Ireland & Nordics

Onsite Location(s):
Hemel Hempstead, HRT, GB

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.

Senior Quality Specialist – UK, Ireland & Nordics 📍
Location: Hemel Hempstead, UK (Hybrid – 3 days per week in the office)

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Travel: Approximately 3 days per month to one of the Nordic countries, at least at the start & may later be ~3 days every two months.

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Salary: The exact salary range depends on someone’s seniority and exact experience.

Advancing science for life – and ensuring it’s done safely

At Boston Scientific, everything we do starts with one goal: improving the lives of patients around the world. We are a global leader in medical technology, driven by innovation and a deep sense of responsibility to the people who rely on our products every day.

We’re now looking for a Senior Quality Specialist to join our UK-based Quality team in Hemel Hempstead. In this role you will be covering the UK, Ireland, and Nordic region and you will be traveling monthly too. In your role, you’ll play a vital role in ensuring that our products and processes remain safe, compliant, and of the highest quality.

Your role in our team

In this role you'll be the guardian of quality and compliance across the UK, Ireland, and Nordics. You’ll represent Quality within the commercial organisation, ensuring that every process, policy, and product aligns with both Boston Scientific’s standards and all regulatory requirements. You’ll be the link between the country commercial teams, our regional/global quality organization.

Your main responsibilities include:

• Maintaining and improving the Quality Management System (QMS) in line with FDA, EU MDR, and ISO 13485 requirements
• Leading audits (internal, external, and supplier) and acting as the subject matter expert during inspections
• Managing product recalls and advisory notices, ensuring timely and accurate communication with customers and sales teams across all divisions
• Investigating and resolving quality issues, identifying root causes and implementing corrective or preventive actions
• Collaborating with cross-functional teams including Regulatory, Customer Care, Sales, and Marketing to ensure understanding of quality requirements
• Driving continuous improvement projects using methodologies such as Lean, 5S, and VIP initiatives
• Acting as a mentor and senior reference point for more junior Quality team members, supporting their development and helping embed a culture of quality awareness

What makes this role unique

Unlike many similar positions, this role offers broad exposure across all business divisions and processes: from logistics and customer service to product distribution and regulatory collaboration.

You’ll have a tangible impact on patient safety and operational excellence while also:

• Working in a truly international and cross-functional environment, with close ties to regional and global Quality teams
• Collaborating with diverse colleagues across the UK, Ireland, and Nordics, with occasional travel (around 2–3 days per month)
• Enjoying the autonomy to lead initiatives, identify improvements, and influence decision-making
• Building your career within one of the world’s most respected medical technology companies

What you bring

You combine technical quality expertise with influencing and stakeholder management skills. You are confident navigating complex organisations and approach challenges with curiosity and professionalism.

Our purple cow should have:

• Minimum 5 years of experience in Quality System Management within the medical device or pharmaceutical industry
• Proven experience with ISO 13485 and related regulatory frameworks (FDA, EU MDR)
• Demonstrated ability to lead audits, manage CAPA…