206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Vollzeitnur vor OrtManagement
Eysins
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
BEBecton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Eysins
ab CHF 158.600 - 253.775 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality oversight for contract manufacturing of medical electromechanical instrumentation at a medical technology leader, including supplier qualification and FDA inspections. Valid Swiss work authorization and 10+ years in electromechanical instrumentation manufacturing required. Global scope, driving quality excellence with Lean/Six Sigma methodologies.
Anforderungen
- Valid Swiss work visa or existing work authorization
- ~10 years senior experience in regulated industries
- Deep expertise in QMS, product design, manufacturing, supply chain
- Extensive knowledge of medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Emotional intelligence
- Ability to influence stakeholders in complex environments
- Ability to build and inspire high-performing teams
- Bachelor’s degree in a technical field (Engineering preferred)
- Master’s degree a plus
- 10+ years experience in electromechanical instrumentation manufacturing
- 10+ years experience in quality assurance in regulated industries
- 10+ years experience in regulatory compliance in regulated industries
- Strong QMS expertise
- Product design knowledge
- Manufacturing knowledge
- Supply chain knowledge
- Ideally electromechanical knowledge
- Deep knowledge of ISO 13485
- Deep knowledge of FDA QSR (21 CFR Part 820)
- Deep knowledge of ISO 14971
- Deep knowledge of international medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Ability to influence stakeholders and drive results in complex environments
Aufgaben
- Lead and develop a Contract Manufacturing Quality team
- Qualify new suppliers
- Conduct supplier audits
- Manage supplier performance
- Champion continuous improvement initiatives
- Apply Lean, Six Sigma, and advanced quality methods
- Partner with design, manufacturing, and supply chain leaders
- Coordinate with procurement leaders
- Resolve challenges across functions
- Enhance supplier capabilities
- Represent the organization during FDA inspections
- Represent the organization during notified body inspections
- Report key metrics and trends to senior leadership
- Shape long-term strategy
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- QMS
- ISO 13485
- FDA QSR (21 CFR Part 820)
- ISO 14971
- Electromechanical instrumentation
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Becton, Dickinson and Company 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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BEBecton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Eysins
ab CHF 158.600 - 253.775 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality oversight for contract manufacturing of medical electromechanical instrumentation at a medical technology leader, including supplier qualification and FDA inspections. Valid Swiss work authorization and 10+ years in electromechanical instrumentation manufacturing required. Global scope, driving quality excellence with Lean/Six Sigma methodologies.
Anforderungen
- Valid Swiss work visa or existing work authorization
- ~10 years senior experience in regulated industries
- Deep expertise in QMS, product design, manufacturing, supply chain
- Extensive knowledge of medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Emotional intelligence
- Ability to influence stakeholders in complex environments
- Ability to build and inspire high-performing teams
- Bachelor’s degree in a technical field (Engineering preferred)
- Master’s degree a plus
- 10+ years experience in electromechanical instrumentation manufacturing
- 10+ years experience in quality assurance in regulated industries
- 10+ years experience in regulatory compliance in regulated industries
- Strong QMS expertise
- Product design knowledge
- Manufacturing knowledge
- Supply chain knowledge
- Ideally electromechanical knowledge
- Deep knowledge of ISO 13485
- Deep knowledge of FDA QSR (21 CFR Part 820)
- Deep knowledge of ISO 14971
- Deep knowledge of international medical device regulations
- Strong leadership skills
- Strong project management skills
- Strong cross-regional coordination skills
- Ability to influence stakeholders and drive results in complex environments
Aufgaben
- Lead and develop a Contract Manufacturing Quality team
- Qualify new suppliers
- Conduct supplier audits
- Manage supplier performance
- Champion continuous improvement initiatives
- Apply Lean, Six Sigma, and advanced quality methods
- Partner with design, manufacturing, and supply chain leaders
- Coordinate with procurement leaders
- Resolve challenges across functions
- Enhance supplier capabilities
- Represent the organization during FDA inspections
- Represent the organization during notified body inspections
- Report key metrics and trends to senior leadership
- Shape long-term strategy
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- QMS
- ISO 13485
- FDA QSR (21 CFR Part 820)
- ISO 14971
- Electromechanical instrumentation
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Becton, Dickinson and Company 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.
Über das Unternehmen
Becton, Dickinson and Company
Branche
Healthcare
Beschreibung
The company is a global leader in medical technology, advancing health through innovation in medical discovery, diagnostics, and care delivery.
Noch nicht perfekt?
- 206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Vollzeitnur vor OrtManagementEysins - Becton, Dickinson and Company
Senior Continuous Improvement Manager – Global Supply Chain(m/w/x)
Vollzeitnur vor OrtManagementEysinsab CHF 143.900 - 230.225 / Jahr - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Becton, Dickinson and Company
Procurement Manager – Contract Manufacturing(m/w/x)
Vollzeitnur vor OrtSeniorEysinsab CHF 121.500 - 185.325 / Jahr - BD Biosciences
EMEA Senior Marketing Manager Life Science Research(m/w/x)
Vollzeitnur vor OrtSeniorEysinsab CHF 160.000 - 205.000 / Jahr