Zollinger Personal GmbH
Leiter Qualitätssicherung Medtech(m/w/x)
Vollzeit
mit Homeoffice
Keine Angabe
Zürich
NL
NL3M Philips International BV11 Tage
Patient Safety and Quality Leader DACH(m/w/x)
Management
Vollzeit
Keine Angabe
8810 Horgen
Nejo KI-Zusammenfassung
In this role, you will oversee regulatory compliance and quality standards while shaping global strategies. Your day-to-day responsibilities will include managing submissions, guiding product design, and fostering a culture of quality excellence across teams.
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Anforderungen
- •Minimum 8 years of experience with Bachelor's or Minimum 6 years of experience with a Master’s in business administration, Legal, Quality Management, Regulatory Affairs, Engineering, Science or equivalent disciplines
- •Demonstrated experience in the Medical Device/Biotech industry or equivalent in areas such as Medical Device, Quality Assurance, Quality Control, Quality Management, Quality Audit, Compliance Coordination or Warehouse Operations, Regulatory Strategy or compliance, International Regulations, Medical Device Regulations, Product Development
- •Minimum 5 years in a leadership position
- •Quality Management Procedures and Methodologies
- •CAPA Methodologies
- •Quality Assurance (QA)
- •Quality Management Systems (QMS)
- •Policy Development
- •Regulatory Compliance
- •Strategic Planning
- •Continuous Improvement
- •Budget Management
- •People Management
- •Business Acumen
- •Lean/Six Sigma Certification
- •ASQ Certified Quality Manager (CQM)
- •Regulatory Affairs Certification (RAC) for Medical Devices
Keine Angabe
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Oversee compliance with regulatory requirements and quality standards
- •Lead comprehensive monitoring systems and delegate responsibilities
- •Communicate and integrate updates into strategic plans
- •Shape and execute global regulatory and quality strategy
- •Align activities with Philips objectives and ensure regulatory compliance
- •Drive compliance with country-specific regulations for product registration
- •Manage submissions, documentation, and issue resolution
- •Influence product design and lifecycle decisions with regulatory strategy
- •Ensure quality and compliance throughout development and market execution
- •Provide oversight of quality management, safety, and compliance
- •Execute recalls, audits, and resolve compliance issues
- •Establish and maintain strategic relationships with regulatory agencies
- •Enforce harmonized regulatory and quality processes across functions
- •Conduct comprehensive management reviews and report on compliance activities
- •Verify product and device compliance with relevant regulations
- •Lead fulfillment of vigilance reporting and post-market requirements
- •Establish quality assurance practices, including audits and metrics monitoring
- •Manage compliance and quality issues, leading cross-functional discussions
- •Provide strategic guidance to leaders across domains
- •Identify opportunities for innovation and foster a culture of quality excellence
- •Execute business transformation initiatives aligned with corporate strategy
- •Lead organizational planning, staffing, budgeting, and methodological changes
- •Drive efficiency, effectiveness, and long-term sustainability
- •Lead succession planning and talent development for quality and regulatory teams
- •Contribute to refinement of organizational strategy and decision-making frameworks
Tools & Technologien
Quality Management Procedures and MethodologiesCAPA MethodologiesQuality Assurance (QA)Quality Management Systems (QMS)Policy DevelopmentRegulatory ComplianceStrategic PlanningContinuous ImprovementBudget ManagementPeople ManagementBusiness AcumenLean/Six Sigma CertificationASQ Certified Quality Manager (CQM)Regulatory Affairs Certification (RAC) for Medical Devices
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens NL3M Philips International BV erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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