Senior Manager, Technical Service – Compliance

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🔥 41 minutes ago

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• Lead global service compliance strategy and execution, ensuring alignment with regulatory and quality standards • Own and maintain the Service QMS, driving consistent implementation across regions • Manage CAPA processes, field actions, and compliance investigations in line with regulatory requirements • Ensure audit and inspection readiness; lead internal and external quality system audits • Own and improve the QCT process (with focus on QCT1), ensuring timely and compliant triage • Develop and deliver quality insights, driving data-based decision-making and continuous improvement • Serve as the key compliance interface across Service, R&D, Regulatory Affairs, and Post-Market Surveillance to ensure end-to-end issue resolution

🎯 Requirements

• Master’s degree within Regulatory, Engineering, STEM or Commercial • 10 years of progressive experience in quality, compliance, or service operations within the medical device industry or related regulated healthcare sector • Deep understanding of ISO 13485, 21 CFR Part 820, MDR, and other global regulatory frameworks • Experience in leading CAPA systems, audit processes, field action coordination, and compliance investigations within a regulated environment • Hands-on experience in Data Analytics and Dashboards through PowerBI and advanced Excel • Proven leadership capability with strong stakeholder communication and the ability to drive change management initiatives • Experience in designing and implementing scalable compliance processes with demonstrated impact on audit outcomes and customer satisfaction metrics • Ability to travel up to 20%, including international travel as required

🏖️ Benefits

• Health care program • Paid time off