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Senior Manager, Technical Service – Compliance
Danaher CorporationSenior Manager overseeing global service compliance strategy for a leading company in life sciences, ensuring regulatory adherence and enhancing operational excellence. Lead audits, compliance investigations, and service quality systems across regions.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading global service compliance strategies and managing quality management systems within the medical device industry. Proficient in regulatory frameworks, CAPA processes, and data analytics to drive continuous improvement and ensure audit readiness.
Highest-signal resume keywords
Service Compliance StrategyQuality Management System (QMS)CAPA ProcessesISO 13485Data Analytics
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ComplianceQuality AssuranceAudit ProcessesField Action CoordinationCAPA SystemsData AnalyticsAdvanced ExcelPowerBIContinuous ImprovementCustomer Satisfaction Metrics
Soft Skills
LeadershipStakeholder CommunicationChange Management
Certifications & Qualifications
Master’s Degree in Regulatory, Engineering, STEM or Commercial
Industry Keywords
Medical Device IndustryRegulated Healthcare Sector21 CFR Part 820MDRGlobal Regulatory Frameworks
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health care program
- Paid time off