Stryker Leibinger GmbH & Co. KG
Ingenieur Fertigung & Prozessqualifizierung, Medizintechnik(m/w/x)
Full-timeTemporary contractOn-siteExperienced
Freiburg im Breisgau
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INIntuitive
Quality Engineer(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Excel
- SPC
- Six Sigma
- FMEA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Intuitive and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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INIntuitive
Quality Engineer(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Excel
- SPC
- Six Sigma
- FMEA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Intuitive and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Intuitive
Industry
Healthcare
Description
The company is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care.
Not a perfect match?
- Stryker Leibinger GmbH & Co. KG
Ingenieur Fertigung & Prozessqualifizierung, Medizintechnik(m/w/x)
Full-timeTemporary contractOn-siteExperiencedFreiburg im Breisgau - Ormed GmbH
Mitarbeiter Qualitätsmanagement(m/w/x)
Full-timeOn-siteExperiencedFreiburg im Breisgau - maxon
Prozessingenieur für Qualität in Entwicklungsprojekten(m/w/x)
Full-timeOn-siteExperiencedSexau - Stryker Leibinger GmbH & Co. KG
Staff Embedded Verification Engineer(m/w/x)
Full-timeOn-siteExperiencedFreiburg im Breisgau - TRUMPF Hüttinger GmbH + Co.KG
Quality Engineer RF/High-Frequency Technology(m/w/x)
Full-timeOn-siteExperiencedFreiburg im Breisgau