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Skills: Market Development, Patient Education, Account Management, Business Partnering, Public Relations
#Boston Scientific Seit 40 Jahren arbeitet Boston Scientific als weltweit führendes Medizintechnikunternehmen an dem Ziel, das Leben von Patienten und Patientinnen zu verbessern. Täglich stellen wir uns den wichtigsten H…
#Boston Scientific Seit 40 Jahren arbeitet Boston Scientific als weltweit führendes Medizintechnikunternehmen an dem Ziel, das Leben von Patienten und Patientinnen zu verbessern. Täglich stellen wir uns den wichtigsten H…
Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness al…
Field Clinical Specialist, Cardiac Rhythm Management (based in Milan)
Milan, Lombardy, Italy · Remote OK
$29k–$38k/yr
Entry level$10B raised
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Field Clinical Specialist, Cardiac Rhythm Management (based in Rome)
Rome, Lazio, Italy · Remote OK
$29k–$38k/yr
Entry level$10B raised
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Additional Location(s): 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 t…
Skills: Clinical Cardiac Electrophysiology, Complex Arrhythmia Management, Clinical Trial Design, Good Clinical Practice (GCP), Medical Device Development
Skills: Clinical Cardiac Electrophysiology, Complex Arrhythmia Management, Clinical Trial Design, Good Clinical Practice (GCP), Medical Device Development
About Us As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’r…
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Watchman Therapy Awareness Representative - Richmond, VA
Richmond, Virginia, United States · On-site
Mid level$10B raised
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CRM Senior Field Clinical Representative - West Los Angeles, CA
Los Angeles, California, United States · On-site
$85k–$105k/yr
Mid level$10B raised
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Full-time
bachelor degree, postgraduate degree
Posted 45d ago
~40 hrs/week
Responsibilities
The Principal Quality Specialist leads quality activities for complex, cross-functional Medical Electrical Equipment programs to ensure regulatory compliance and project delivery. They drive organizational change and governance by aligning global teams and implementing scalable quality frameworks across all program phases.
Requirements
Candidates must hold a Bachelor’s or Master’s degree in engineering, Quality, or Life Sciences with at least 5 years of experience in Quality Systems within the medical device industry. Strong project management, regulatory knowledge, and the ability to influence stakeholders in a matrixed global environment are essential.
Full 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 knowledge
Excellent stakeholder management and influencing skills
Structured, analytical mindset
Ability to operate effectively in ambiguous or evolving environments, where requirements are not fully defined.
Requisition ID: 630828
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 at www.bostonscientific.com and follow us on LinkedIn.
Related keywords
Quality SpecialistMedical DevicesMEECapital EquipmentISO 13485EU MDR21 CFR Part 820Quality SystemsCAPARoot Cause AnalysisChange ManagementRegulatory StandardsProject ManagementRisk MitigationCross-functional CollaborationQuality Governance
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 40 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 health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.
For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook.
At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers.
You may also review our social media guidelines at http://www.bostonscientific.com/social.
Offices: 100 Boston Scientific Way, Marlborough, MA 01752, US · 25155 Rye Canyon Loop, Santa Clarita, CA 91355, US · 2, Rue René Caudron, Voisins-le-Bretonneux, Ile-de-France 78960, FR · 9 N Buona Vista Dr, Singapore, 13, SG · 4100 N Hamline Ave, St Paul, Minnesota 55112, US
Health DiagnosticsHealth CareMedical DeviceWellnessBiotechnologyManagement Information SystemsMedicalFinancial ServicesManufacturing
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 40 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 health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.
For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook.
At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers.
You may also review our social media guidelines at http://www.bostonscientific.com/social.
Offices: 100 Boston Scientific Way, Marlborough, MA 01752, US · 25155 Rye Canyon Loop, Santa Clarita, CA 91355, US · 2, Rue René Caudron, Voisins-le-Bretonneux, Ile-de-France 78960, FR · 9 N Buona Vista Dr, Singapore, 13, SG · 4100 N Hamline Ave, St Paul, Minnesota 55112, US
Health DiagnosticsHealth CareMedical DeviceWellnessBiotechnologyManagement Information SystemsMedicalFinancial ServicesManufacturing