SUSONITY
Senior Director, Head of Inspection & TMF Center of Excellence(m/w/x)
Vollzeitnur vor OrtSenior
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BDBD Switzerland Sarl
Vice President Quality Management, Operations(m/w/x)
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Developing and implementing strategic quality plans for a global medical technology company. Bachelor's degree in a technical field required, engineering degree strongly preferred. Partnering with business and compliance leaders, driving CI through L6S methodologies.
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Anforderungen
- Bachelor's degree in technical field
- Engineering degree strongly preferred
- Proven experience in Quality Assurance/Control
- Proven experience in Statistical analysis
- Proven experience in FDA QSR’s (21 CFR Part 820)
- Proven experience in lean manufacturing
- Proven experience in risk management (ISO 14971)
- Proven experience in ISO/EC (MDD/MDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements
- Highly qualified in project management
- Interpersonal and motivational skills
- Capability to handle parallel projects and activities
- Ability to lead by influence
- Preparation, planning, and presentation of key initiatives
- Ability to coordinate optimally across regions
Aufgaben
- Develop and implement strategic quality plans
- Partner with business and compliance leaders
- Drive CI through L6S methodologies
- Ensure quality strategies align with business needs
- Assess and address emerging quality issues
- Provide executive-level recommendations
- Build and improve Quality Management function
- Promote certifications in ASQ, Six Sigma
- Embed strong process management culture
- Support business strategies with Quality Management
- Participate in executive Management Reviews
- Ensure quality personnel training and qualification
- Harmonize quality initiatives globally
- Remediate significant quality and manufacturing issues
- Serve on Quality Leadership Teams
- Shape quality strategy and business performance
- Execute CAPA processes for quality improvements
- Maintain robust audit program
- Partner with Manufacturing, R&D, Commercial teams
- Supervise quality performance metrics
- Investigate and resolve product complaints
- Ensure long-term prevention of product issues
- Safeguard product integrity and reliability
- Lead and inspire Quality Management teams
- Develop culture of quality and continuous learning
- Oversee supplier and vendor quality programs
- Drive teamwork and knowledge sharing
- Promote quality and regulatory intelligence sharing
- Influence enterprise-wide quality performance
Berufserfahrung
ca. 1 - 4 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
ISO 14971ISO/ECMDD/MDRMDSAPCMDRISO 13485J-PAL21 CFR Part 820
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens BD Switzerland Sarl 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 BD Switzerland SarlÜber das Unternehmen
BD
HealthcareEysins
BD is one of the largest global medical technology companies in the world, advancing health through its purpose.
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