Stryker Leibinger GmbH & Co. KG
Ingenieur Fertigung & Prozessqualifizierung, Medizintechnik(m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahren
Freiburg im Breisgau
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
INIntuitive
Quality Engineer(m/w/x)
Freiburg im Breisgau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining quality metrics for robotic-assisted surgical devices. 5+ years in quality engineering, with 3 years in medical device manufacturing, required. Advanced degree preferred, with participation in quality improvement projects.
Anforderungen
- Bachelor’s degree in electrical, mechanical, system engineering, math, or physics
- Advanced degree preferred
- 5+ years working experience in Quality Engineering or Process Engineering
- Quality improvement projects participation
- Minimum 3 years in medical device design or manufacturing
- Navigate quality and compliance system with minimal oversight
- Understanding of CFR 21 820/ ISO 13485 requirements
- Understanding of product risk management
- Experience in generating FMEA and process FMEA
- Understanding of Design Controls, Change Controls, Product, and Engineering Processes
- Proficient with generating and executing Qualification and Validation protocols
- Proficient with Quality Assurance Procedures
- Experience in leading product containment and rework activities
- Proficient in SPC & Six Sigma methodology and tools
- Experienced in typical Excel data analysis operations
- Able to create Multi-source reports, trends, and interpret data with minimal oversight
- Independent thinking and decision-making based on limited information
- Initiating improvement discussions and leading team toward goal
- Presenting information in various forms and forums
- Collaborating with peers across functions
- Experience in presenting to cross-functional management
- Excellent creative problem-solving skills
- Excellent communication and documentation skills in English
- Excellent communication and documentation skills in German
Aufgaben
- Define practical quality metrics and specifications
- Identify opportunities for product improvement
- Launch quality initiatives
- Lead projects to implement quality initiatives
- Consult to solve challenging quality problems
- Handle product and subsystem projects
- Develop measurable quality goals
- Lead Quality Table meetings
- Mitigate essential performance aspects in product quality plans
- Identify critical design elements
- Recommend design processes for quality goals
- Provide guidance on regulatory requirements
- Plan quality standards and procedures
- Create quality control and assurance plans
- Develop test methods, fixtures, and processes
- Ensure process compliance through documentation
- Analyze and disposition discrepant material
- Support manufacturing processes
- Perform failure analysis
- Review and approve documentation
- Qualify tooling and inspection methods
- Contain defects
- Support process validation and verification
- Support manufacturing line qualification
- Drive MVP/R projects
- Provide quality expertise for failure analysis
- Perform deep technical failure analysis
- Interpret complex data analysis
- Create, process, and review Quality Notifications
- Create, process, and review Change Orders
- Develop corporate level quality metrics
- Lead Quality Data Review meetings
- Lead quality initiatives in product, data, or process quality
- Perform mock audits
- Conduct Gemba walks for QMS compliance
- Participate in audits
- Develop intercompany Quality Engineering projects
- Lead intercompany Quality Engineering projects
- Communicate intercompany Quality Engineering projects
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Excel
- SPC
- Six Sigma
- FMEA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Intuitive 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.
Noch nicht perfekt?
- Ormed GmbH
Mitarbeiter Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtBerufserfahrenFreiburg im Breisgau - maxon
Prozessingenieur für Qualität in Entwicklungsprojekten(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSexau - Stryker Leibinger GmbH & Co. KG
Staff Embedded Verification Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenFreiburg im Breisgau - TRUMPF Hüttinger GmbH + Co.KG
Quality Engineer RF/High-Frequency Technology(m/w/x)
Vollzeitnur vor OrtBerufserfahrenFreiburg im Breisgau
INIntuitive
Quality Engineer(m/w/x)
Freiburg im Breisgau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining quality metrics for robotic-assisted surgical devices. 5+ years in quality engineering, with 3 years in medical device manufacturing, required. Advanced degree preferred, with participation in quality improvement projects.
Anforderungen
- Bachelor’s degree in electrical, mechanical, system engineering, math, or physics
- Advanced degree preferred
- 5+ years working experience in Quality Engineering or Process Engineering
- Quality improvement projects participation
- Minimum 3 years in medical device design or manufacturing
- Navigate quality and compliance system with minimal oversight
- Understanding of CFR 21 820/ ISO 13485 requirements
- Understanding of product risk management
- Experience in generating FMEA and process FMEA
- Understanding of Design Controls, Change Controls, Product, and Engineering Processes
- Proficient with generating and executing Qualification and Validation protocols
- Proficient with Quality Assurance Procedures
- Experience in leading product containment and rework activities
- Proficient in SPC & Six Sigma methodology and tools
- Experienced in typical Excel data analysis operations
- Able to create Multi-source reports, trends, and interpret data with minimal oversight
- Independent thinking and decision-making based on limited information
- Initiating improvement discussions and leading team toward goal
- Presenting information in various forms and forums
- Collaborating with peers across functions
- Experience in presenting to cross-functional management
- Excellent creative problem-solving skills
- Excellent communication and documentation skills in English
- Excellent communication and documentation skills in German
Aufgaben
- Define practical quality metrics and specifications
- Identify opportunities for product improvement
- Launch quality initiatives
- Lead projects to implement quality initiatives
- Consult to solve challenging quality problems
- Handle product and subsystem projects
- Develop measurable quality goals
- Lead Quality Table meetings
- Mitigate essential performance aspects in product quality plans
- Identify critical design elements
- Recommend design processes for quality goals
- Provide guidance on regulatory requirements
- Plan quality standards and procedures
- Create quality control and assurance plans
- Develop test methods, fixtures, and processes
- Ensure process compliance through documentation
- Analyze and disposition discrepant material
- Support manufacturing processes
- Perform failure analysis
- Review and approve documentation
- Qualify tooling and inspection methods
- Contain defects
- Support process validation and verification
- Support manufacturing line qualification
- Drive MVP/R projects
- Provide quality expertise for failure analysis
- Perform deep technical failure analysis
- Interpret complex data analysis
- Create, process, and review Quality Notifications
- Create, process, and review Change Orders
- Develop corporate level quality metrics
- Lead Quality Data Review meetings
- Lead quality initiatives in product, data, or process quality
- Perform mock audits
- Conduct Gemba walks for QMS compliance
- Participate in audits
- Develop intercompany Quality Engineering projects
- Lead intercompany Quality Engineering projects
- Communicate intercompany Quality Engineering projects
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Excel
- SPC
- Six Sigma
- FMEA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Intuitive 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
Intuitive
Branche
Healthcare
Beschreibung
The company is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care.
Noch nicht perfekt?
- Stryker Leibinger GmbH & Co. KG
Ingenieur Fertigung & Prozessqualifizierung, Medizintechnik(m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahrenFreiburg im Breisgau - Ormed GmbH
Mitarbeiter Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtBerufserfahrenFreiburg im Breisgau - maxon
Prozessingenieur für Qualität in Entwicklungsprojekten(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSexau - Stryker Leibinger GmbH & Co. KG
Staff Embedded Verification Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenFreiburg im Breisgau - TRUMPF Hüttinger GmbH + Co.KG
Quality Engineer RF/High-Frequency Technology(m/w/x)
Vollzeitnur vor OrtBerufserfahrenFreiburg im Breisgau