Principal Quality Specialist

Boston Scientific; Kerkrade; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Boston Scientific seeks a Principal Quality Specialist to lead quality programs in Medical Electrical Equipment (MEE) and Capital Equipment. You will drive development, implementation, and governance of quality frameworks across global, cross-functional programs with autonomy and accountability.

The role requires strong leadership in quality systems, project execution, and change management, ensuring compliance with ISO 13485, EU MDR 2017/745, and 21 CFR Part 820.

Qualifications

• Bachelor’s or Master’s degree in engineering, Quality, Life Sciences, or related field.
• 5+ years Quality Systems experience in Medical Devices / MEE / Capital Equipment.
• Proven experience leading large-scale, cross-functional and/or global programs.
• Experience in change management and transformation initiatives.
• Strong interpersonal communication, collaboration and influencing skills.
• Structured, analytical mindset and ability to operate in evolving environments.

Responsibilities

• Lead quality activities for complex, cross-functional MEE/Capital Equipment programs with milestones and timelines.
• Drive execution across regional and global teams, aligning Quality, Regulatory, Supply Chain, Service, and Commercial functions.
• Serve as expert in Quality Systems, ensuring compliance with ISO 13485, EU MDR 2017/745, and 21 CFR Part 820.
• Lead or support CAPA, root cause analysis, and continuous improvement initiatives.
• Collaborate with cross-functional colleagues regarding impacts of enhancements and process changes.
• Promote best industry practices and drive quality leadership within the group; influence EMEA Quality leaders on critical decisions.
• Drive change management and adoption of new processes, systems, and ways of working in a matrixed global organization.

Skills

Quality leadership

Project management

Cross-functional collaboration

Stakeholder management

Change management

Regulatory knowledge

Communication skills

Analytical mindset

Education

Engineering degree

Quality/Life Sciences degree

Job description

Additional Locations: Netherlands-Kerkrade; France-Voisins le Bretonneux; Germany-Düsseldorf; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; Italy-Milan; Spain-Madrid; United Kingdom-Hemel Hempstead

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.

About The Role

The Principal Quality Specialist serves as a senior Quality leader supporting large-scale, complex initiatives within the Medical Electrical Equipment (MEE) / Capital Equipment domain. You will drive the development, implementation, and governance of quality frameworks across global, cross-functional programs.

We are looking for a candidate with strong leadership in quality systems, project execution, and organizational change, ensuring alignment with regulatory requirements, corporate quality goals, and operational excellence. The role operates with a high degree of autonomy and influences strategic decision-making across multiple functions and regions.

This position will be either hybrid or onsite located at Kerkrade in the Netherlands or at one of the EMEA Hub locations.

Key Responsibilities

• Lead Quality activities for complex, cross-functional Medical Electrical Equipment (MEE)/Capital Equipment programs, ensuring delivery against objectives, milestones, and timelines through robust project planning and risk mitigation.
• Drive execution across regional and global teams, aligning Quality, Regulatory, Supply Chain, Service, and commercial functions while proactively managing risks, issues, and dependencies.
• Serve as a subject matter expert in Quality Systems, ensuring compliance with applicable regulatory standards such as ISO 13485, EU MDR 2017/745, and 21 CFR Part 820, and embedding scalable Quality frameworks across all program phases from concept through sustainment.
• Lead or support CAPA, root cause analysis, and continuous improvement initiatives to resolve systemic issues and enhance overall performance.
• Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
• Is viewed as a leader in the areas of QSR and ISO/MDR standards within one’s own group, constantly promoting awareness of best industry practices making appropriate decisions while collaborating with EMEA Quality leaders as appropriate on critical quality decisions.
• Drive change management and cross-functional engagement by influencing decision-making, building stakeholder alignment, and enabling adoption of new processes, systems, and ways of working in a matrixed global organization.

Requirements

• Bachelor’s or Master’s degree in engineering, Quality, Life Sciences, or related field
• 5+ years Quality Systems experience in within Medical Devices / Medical Electrical Equipment (MEE) / Capital Equipment.
• Previous experience in Capital Equipment space is preferable.
• Proven experience leading large-scale, cross-functional and/or global programs
• Experience in change management and transformation initiatives
• Team player with strong work ethics and positive mentality
• Strong project and program management capability
• Strong interpersonal communication, collaboration and influencing skills
• Deep regulatory and quality systems knowledgeExcellent stakeholder management and influencing skills
• Structured, analytical mindset
• Ability to operate effectively in ambiguous or evolving environments, where requirements are not fully defined.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more atwww.bostonscientific.comand follow us onLinkedIn.