Senior Quality Specialist - UK, Ireland & Nordics

Boston Scientific Gruppe; Hemel Hempstead; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A global medical device leader is seeking a Senior Quality Specialist to ensure compliance with quality standards across the UK, Ireland, and Nordics. The role involves maintaining quality management systems, leading audits, and driving continuous improvement projects. Ideal candidates have a minimum of 5 years in quality management in the medical field and expertise in ISO 13485. This position offers a hybrid work model with competitive benefits.

Benefits

Competitive salary

Professional growth opportunities

Supportive team environment

Qualifications

• 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.
• Demonstrated ability to lead audits and manage CAPA processes.

Responsibilities

• Maintaining and improving the Quality Management System (QMS).
• Leading audits and acting as the subject matter expert during inspections.
• Managing product recalls and advisory notices.

Skills

Quality System Management

Stakeholder management

Regulatory frameworks (FDA, EU MDR)

Continuous improvement methods (Lean, 5S)

Job description

Overview

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

Travel: Approximately 3 days per month to Nordic countries, and may later be ~3 days every two months. Salary: The exact salary range depends on seniority and experience.

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.

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 Boston Scientific’s standards and regulatory requirements. You’ll be the link between country commercial teams and our regional/global quality organization.

Responsibilities

• 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 embedding a culture of quality awareness

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.

• 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 processes, and improve documentation controls
• Experience in distribution centre and logistics quality oversight

What we offer

In addition to a competitive salary and benefits package, you’ll join a supportive, high-performing team that values professional growth and continuous learning. You’ll have the chance to work on meaningful projects that directly impact patient safety, all within a company recognised for innovation, ethics, and purpose.

Hybrid work is standard for this role, with flexibility to work from home up to two days a week. Occasional travel within the region (UKI and Nordics) will be required.

At Boston Scientific, quality is more than a process – it’s a promise. In this role, you’ll help uphold that promise every day by ensuring our products meet the highest standards of safety, reliability, and performance.

If you’re a detail-driven quality professional who enjoys working across functions, influencing others, and continuously improving how things are done, we’d love to hear from you.

Apply now and be part of a team that’s advancing science for life.

Boston Scientific is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The process is a three-stage one: a 30-minute interview with our recruiter, a 1 hour interview with the manager and a final assessment based panel-interview.

Requisition ID:617142

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!

Job Segment: Pharmaceutical, Compliance, Law, Medical Device, CAPA, Science, Healthcare, Management

Expiry: This job description does not indicate closure; if the role is closed please disregard.