Senior Quality Specialist - UK, Ireland & Nordics at Boston Scientific Corporation Malaysia

Hemel Hempstead, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

28 Jan, 26

Salary

0.0

Posted On

30 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality System Management, ISO 13485, FDA Regulations, EU MDR, Auditing, CAPA Processes, Documentation Controls, Logistics Quality Oversight, Communication Skills, Stakeholder Management, Continuous Improvement, Lean Methodologies, 5S, Mentoring, Problem Solving, Curiosity, Professionalism

Industry

Medical Equipment Manufacturing

Description

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) ✈️ 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. ? 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 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 This role, in some other companies known as Senior Quality Manager, 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 act as a key link between our manufacturing sites, commercial teams, and customers and are the one driving improvements, managing audits, and helping others understand and apply quality principles in their daily work. 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 processes, and improve documentation controls Experience in distribution centre and logistics quality oversight Beyond your technical expertise, you bring strong communication and stakeholder management skills. You're the kind of person with the confidence to guide, train, and influence others, and a proactive, solution-oriented mindset that helps you drive continuous improvement. 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. Why join us 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!

Responsibilities

The Senior Quality Specialist will maintain and improve the Quality Management System in compliance with regulatory requirements and lead audits while managing product recalls and quality issues. This role involves collaboration with cross-functional teams to ensure quality standards are met and driving continuous improvement initiatives.