SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Tolochenaz, Lausanne
ab CHF 144.000 / Jahr
Neuer Job?Nejo!
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SMSMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
Tolochenaz
ab CHF 92.000 - 138.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Design transfer from R&D to manufacturing for medical devices, managing risk and validation. Strong QMS knowledge (ISO 13485, MDSAP) and Design Controls experience required. Work in a highly regulated medical device environment.
Anforderungen
- Master’s degree or equivalent
- English min B2
- Strong working knowledge of QMS compliant with ISO 13485, MDSAP, and global regulations
- Hands-on experience with Design Controls
- Experience supporting regulatory inspections and audits (FDA, Notified Bodies)
- Solid understanding of software and/or hardware validation
- Cross-functional collaboration with R&D, Manufacturing, Regulatory Affairs, Supplier Quality
- Strong documentation, analytical, and problem-solving skills
- Experience supporting pre-market quality activities in product/process development
- Working knowledge of design transfer and industrialization in medical device environment
- Experience contributing to pre-market documentation (DHF, risk management, validation)
Aufgaben
- Support design transfer from R&D to Manufacturing
- Manage risk management activities for design transfer
- Conduct process validation for design transfer
- Ensure manufacturing readiness for design transfer
- Partner with project teams for quality and regulatory readiness
- Develop and maintain quality standards for material processing
- Collaborate with development team on NPI initiatives
- Define strategies for process and equipment validation
- Support process characterization using DfR/DfM
- Collaborate with engineering and manufacturing on quality standards
- Devise and implement methods for product inspection
- Devise and implement methods for equipment inspection
- Devise and implement methods for product testing
- Devise and implement methods for equipment testing
- Evaluate precision and accuracy of products and equipment
- Design or specify inspection and testing equipment
- Conduct quality assurance tests
- Perform statistical analysis on non-conforming products
- Ensure corrective measures meet reliability standards
- Ensure documentation complies with requirements
- Provide quality support for pre-market projects
- Support product and process development
- Support industrialization activities
- Support product transfer activities
- Define and execute quality deliverables during development
- Ensure compliance with Design Control requirements
Berufserfahrung
- 2 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 13485
- MDSAP
- FDA
- Notified Bodies
- Design History File (DHF)
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SMO Medtronic Europe Sàrl 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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Associate Calibration Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 123.480 / Jahr - SMO Medtronic Europe Sàrl
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SMSMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
Tolochenaz
ab CHF 92.000 - 138.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Design transfer from R&D to manufacturing for medical devices, managing risk and validation. Strong QMS knowledge (ISO 13485, MDSAP) and Design Controls experience required. Work in a highly regulated medical device environment.
Anforderungen
- Master’s degree or equivalent
- English min B2
- Strong working knowledge of QMS compliant with ISO 13485, MDSAP, and global regulations
- Hands-on experience with Design Controls
- Experience supporting regulatory inspections and audits (FDA, Notified Bodies)
- Solid understanding of software and/or hardware validation
- Cross-functional collaboration with R&D, Manufacturing, Regulatory Affairs, Supplier Quality
- Strong documentation, analytical, and problem-solving skills
- Experience supporting pre-market quality activities in product/process development
- Working knowledge of design transfer and industrialization in medical device environment
- Experience contributing to pre-market documentation (DHF, risk management, validation)
Aufgaben
- Support design transfer from R&D to Manufacturing
- Manage risk management activities for design transfer
- Conduct process validation for design transfer
- Ensure manufacturing readiness for design transfer
- Partner with project teams for quality and regulatory readiness
- Develop and maintain quality standards for material processing
- Collaborate with development team on NPI initiatives
- Define strategies for process and equipment validation
- Support process characterization using DfR/DfM
- Collaborate with engineering and manufacturing on quality standards
- Devise and implement methods for product inspection
- Devise and implement methods for equipment inspection
- Devise and implement methods for product testing
- Devise and implement methods for equipment testing
- Evaluate precision and accuracy of products and equipment
- Design or specify inspection and testing equipment
- Conduct quality assurance tests
- Perform statistical analysis on non-conforming products
- Ensure corrective measures meet reliability standards
- Ensure documentation complies with requirements
- Provide quality support for pre-market projects
- Support product and process development
- Support industrialization activities
- Support product transfer activities
- Define and execute quality deliverables during development
- Ensure compliance with Design Control requirements
Berufserfahrung
- 2 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 13485
- MDSAP
- FDA
- Notified Bodies
- Design History File (DHF)
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SMO Medtronic Europe Sàrl 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
SMO Medtronic Europe Sàrl
Branche
Healthcare
Beschreibung
The company leads global healthcare technology and addresses challenging health problems through innovative solutions.
Noch nicht perfekt?
- SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenTolochenaz, Lausanneab CHF 144.000 / Jahr - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 144.000 / Jahr - SICPA SA
Operational Quality Engineer(m/w/x)
Vollzeitnur vor OrtSeniorPrilly - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 123.480 / Jahr - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Vollzeitnur vor OrtJuniorLausanneab CHF 123.480 / Jahr