Zühlke Engineering AG
Senior QA Consultant(m/w/x)
Vollzeitmit HomeofficeSenior
Schlieren
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
NDndd Medizintechnik AG
Quality & Regulatory Affairs Manager(m/w/x)
Zürich
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Improving lung function testing accessibility with QMS and regulatory compliance. 5+ years medical device QA/RA experience required. Flexible hours, hybrid work, modern tech.
Anforderungen
- Bachelor's or Master's degree in biomedical engineering, life science, or comparable technical/scientific field
- At least 5 years of professional experience in quality management, quality assurance, and regulatory affairs within the medical device industry
- Proven experience with QMS, audits, supplier management, and product development projects
- Solid knowledge of medical device regulations and applicable standards
- Strong understanding of Quality Management Systems, risk management, and product lifecycle processes
- Structured, analytical, and quality-focused working style
- Ability to work independently and cross-functionally
- Strong communication skills and confidence in interaction with stakeholders
- Leadership and decision-making capabilities
- Leadership experience in quality functions is an advantage
- Strong knowledge of ISO 13485, QMSR, ISO 14971, IEC 60601-1
- Excellent knowledge of documentation and quality tools
- Professional fluency in English
- Professional fluency in German
- Additional languages are a plus
Aufgaben
- Maintain and improve Quality Management System
- Ensure compliance with regulatory requirements
- Maintain effective document control and record keeping
- Prepare and update quality reports
- Support internal and external audits
- Follow up on audit findings
- Ensure regulatory compliance in all markets
- Support product registrations and changes
- Monitor regulatory changes and assess impacts
- Coordinate third-party testing activities
- Lead supplier quality activities
- Monitor supplier performance
- Manage supplier nonconformities
- Support customer quality issues
- Investigate and resolve customer complaints
- Evaluate customer feedback
- Manage CAPA activities
- Conduct root cause analysis
- Implement and verify CAPA effectiveness
- Support Engineering Change Orders
- Ensure quality and regulatory compliance in ECOs
- Maintain documentation integrity
- Support Post Market Surveillance
- Collect and evaluate PMS data
- Support risk management activities
- Ensure PMS and risk outputs are reflected in CAPA
- Update product labelling and documentation
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- Polarion
- Salesforce
- ISO 13485
- QMSR
- ISO 14971
- IEC 60601-1
Benefits
Flexibles Arbeiten
- Flexible working hours
- Hybrid work
Sonstige Vorteile
- Comprehensive onboarding
- Equal opportunities
- Diversity
- Inclusion
Moderne Technikausstattung
- Professional and modern technology
Lockere Unternehmenskultur
- Collegial and supportive working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ndd Medizintechnik AG 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- Climeworks
Senior Quality Specialist(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorOpfikon - KLK Kolb Schweiz
Senior Quality Assurance Expert(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorHedingen - WILCO AG
Quality Manager(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenWohlen - See Spital
Leiter:in Qualitätsmanagement(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorHorgen
NDndd Medizintechnik AG
Quality & Regulatory Affairs Manager(m/w/x)
Zürich
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Improving lung function testing accessibility with QMS and regulatory compliance. 5+ years medical device QA/RA experience required. Flexible hours, hybrid work, modern tech.
Anforderungen
- Bachelor's or Master's degree in biomedical engineering, life science, or comparable technical/scientific field
- At least 5 years of professional experience in quality management, quality assurance, and regulatory affairs within the medical device industry
- Proven experience with QMS, audits, supplier management, and product development projects
- Solid knowledge of medical device regulations and applicable standards
- Strong understanding of Quality Management Systems, risk management, and product lifecycle processes
- Structured, analytical, and quality-focused working style
- Ability to work independently and cross-functionally
- Strong communication skills and confidence in interaction with stakeholders
- Leadership and decision-making capabilities
- Leadership experience in quality functions is an advantage
- Strong knowledge of ISO 13485, QMSR, ISO 14971, IEC 60601-1
- Excellent knowledge of documentation and quality tools
- Professional fluency in English
- Professional fluency in German
- Additional languages are a plus
Aufgaben
- Maintain and improve Quality Management System
- Ensure compliance with regulatory requirements
- Maintain effective document control and record keeping
- Prepare and update quality reports
- Support internal and external audits
- Follow up on audit findings
- Ensure regulatory compliance in all markets
- Support product registrations and changes
- Monitor regulatory changes and assess impacts
- Coordinate third-party testing activities
- Lead supplier quality activities
- Monitor supplier performance
- Manage supplier nonconformities
- Support customer quality issues
- Investigate and resolve customer complaints
- Evaluate customer feedback
- Manage CAPA activities
- Conduct root cause analysis
- Implement and verify CAPA effectiveness
- Support Engineering Change Orders
- Ensure quality and regulatory compliance in ECOs
- Maintain documentation integrity
- Support Post Market Surveillance
- Collect and evaluate PMS data
- Support risk management activities
- Ensure PMS and risk outputs are reflected in CAPA
- Update product labelling and documentation
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- Polarion
- Salesforce
- ISO 13485
- QMSR
- ISO 14971
- IEC 60601-1
Benefits
Flexibles Arbeiten
- Flexible working hours
- Hybrid work
Sonstige Vorteile
- Comprehensive onboarding
- Equal opportunities
- Diversity
- Inclusion
Moderne Technikausstattung
- Professional and modern technology
Lockere Unternehmenskultur
- Collegial and supportive working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ndd Medizintechnik AG 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
ndd Medizintechnik AG
Branche
Healthcare
Beschreibung
ndd Medizintechnik AG is a leading innovator in pulmonary function testing devices, improving early detection of chronic lung diseases with spirometry devices sold in over 100 countries.
Noch nicht perfekt?
- Zühlke Engineering AG
Senior QA Consultant(m/w/x)
Vollzeitmit HomeofficeSeniorSchlieren - Climeworks
Senior Quality Specialist(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorOpfikon - KLK Kolb Schweiz
Senior Quality Assurance Expert(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorHedingen - WILCO AG
Quality Manager(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenWohlen - See Spital
Leiter:in Qualitätsmanagement(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorHorgen