Integra LifeSciences Switzerland Sàrl
Associate Quality Assurance(m/w/x)
Vollzeitnur vor OrtSenior
Le Locle
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ININTEGRA LIFESCIENCES CORP
Senior Director, Quality Operations EU(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Strategic and operational leadership for Quality Assurance across multiple EU manufacturing sites. 10-12 years progressive Quality experience in medical devices required. Oversight of 3 sites, partnership with site leadership and corporate quality.
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Anforderungen
- Bachelor’s degree in Engineering, Life Sciences, or related technical discipline
- Advanced degree preferred
- 10–12 years progressive Quality experience
- Experience in medical device or regulated healthcare industry
- Demonstrated experience leading Quality organizations
- Experience in a manufacturing environment
- Strong working knowledge of global Quality requirements
- Strong working knowledge of global regulatory requirements
- Knowledge of FDA QSR
- Knowledge of ISO 13485
- Knowledge of EU MDR
- Proven experience leading regulatory inspections
- Proven experience leading regulatory audits
- Experience managing across multiple sites
- Experience managing complex organizations
- Fluent in English
- Fluent in French
- Prior experience in Director-level Quality leadership role
- Prior experience in equivalent senior Quality leadership role
- Experience serving as a span-breaker leader
- Experience serving as a matrix leader
- Experience across geographically dispersed sites
- Strong change leadership mindset
- Continuous improvement mindset
- Lean experience preferred
- Six Sigma experience preferred
- Similar continuous improvement experience preferred
- Experience working within a global organization
- Experience working within a multinational organization
Aufgaben
- Provide strategic and operational leadership for Quality Assurance
- Oversee Quality operations for Le Locle, St. Aubin, and RW sites
- Partner with Site Leadership, Operations, Regulatory, and Corporate Quality
- Lead and direct site Quality Assurance teams
- Serve as primary Quality liaison and escalation point
- Translate global Quality strategy into site-level execution
- Advise site leadership on Quality, risk management, and compliance
- Implement Quality Management System (QMS) processes
- Drive harmonization of Quality processes across sites
- Oversee management review processes
- Escalate quality risks and performance trends
- Ensure compliance with FDA QSR, ISO 13485, EU MDR, and other regulations
- Prepare sites for regulatory authority inspections and audits
- Lead regulatory authority inspections and customer audits
- Review and approve responses to inspection observations
- Support production while maintaining compliance and quality standards
- Lead deviations, investigations, and product impact assessments
- Make product release decisions
- Manage changes in processes, equipment, and products
- Conduct root cause analysis and develop CAPA
- Execute CAPA with measurable outcomes
- Use quality metrics and trend analysis to identify risks
- Lead continuous improvement initiatives
- Develop and mentor Quality leaders and team members
- Build strong succession pipelines
- Foster a culture of accountability and continuous learning
- Ensure appropriate training and competency for Quality personnel
Berufserfahrung
10 - 12 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – fließend
Französisch – fließend
Tools & Technologien
FDA QSRISO 13485EU MDRLeanSix Sigma
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens INTEGRA LIFESCIENCES CORP 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.
Zur Originalanzeige bei INTEGRA LIFESCIENCES CORPÜber das Unternehmen
IN
ManufacturingLe Locle
The company is focused on improving healthcare outcomes through innovative solutions.
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