F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Full-timeOn-siteSenior
Basel
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RORoche
Device Supplier Quality Manager(m/w/x)
Basel
Full-timeOn-siteExperienced
Nejo AI Summary
Quality assurance oversight for external GxP suppliers of medical devices and combination products at global biotechnology firm. Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971 required. International collaboration with GxP suppliers.
Requirements
- Engineering or Science degree
- Thorough understanding of biotechnology industry, combination products, medical devices
- Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971
- Sound understanding of Quality Compliance, Quality Engineering, Audits & Inspections Management
- Ability to educate on Design Controls (medical devices, combination products)
- Demonstrated capability in risk management concepts and tools
- Well-developed teamwork and collaboration skills
- Clear, professional verbal and written communication
- Fluency in English
- Fluency in a second language (plus)
- Demonstrated problem solving and decision-making skills
- Hands-on experience with quality-related tools, Six Sigma / DMAIC
- Experience in agile environment
- Usage of lean tools
Tasks
- Provide quality assurance oversight for external GxP suppliers.
- Ensure medical device and combination product compliance with regulations, standards, and Roche requirements.
- Oversee quality activities throughout the GxP supplier lifecycle.
- Manage method validation processes.
- Coordinate Roche and Health Authority audits.
- Oversee complaint handling procedures.
- Manage regulatory submissions.
- Serve as SME for supplier qualification audits.
- Serve as SME for supplier maintenance audits.
- Perform quality assurance for supplier change controls and deviations.
- Facilitate systematic root cause assessments (RCA).
- Coordinate quality support for medical devices and combination products.
- Collaborate with local QA/QC teams on clinical and commercial release.
- Set work priorities for project targets and timelines.
- Maintain up-to-date job-related training status.
- Improve knowledge and skills in quality, compliance, and technology.
- Notify management of potential quality or regulatory issues.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- 21 CFR 820
- EU MDR
- ISO 14971
- Six Sigma
- DMAIC
- Lean tools
- Agile
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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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RORoche
Device Supplier Quality Manager(m/w/x)
Basel
Full-timeOn-siteExperienced
Nejo AI Summary
Quality assurance oversight for external GxP suppliers of medical devices and combination products at global biotechnology firm. Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971 required. International collaboration with GxP suppliers.
Requirements
- Engineering or Science degree
- Thorough understanding of biotechnology industry, combination products, medical devices
- Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971
- Sound understanding of Quality Compliance, Quality Engineering, Audits & Inspections Management
- Ability to educate on Design Controls (medical devices, combination products)
- Demonstrated capability in risk management concepts and tools
- Well-developed teamwork and collaboration skills
- Clear, professional verbal and written communication
- Fluency in English
- Fluency in a second language (plus)
- Demonstrated problem solving and decision-making skills
- Hands-on experience with quality-related tools, Six Sigma / DMAIC
- Experience in agile environment
- Usage of lean tools
Tasks
- Provide quality assurance oversight for external GxP suppliers.
- Ensure medical device and combination product compliance with regulations, standards, and Roche requirements.
- Oversee quality activities throughout the GxP supplier lifecycle.
- Manage method validation processes.
- Coordinate Roche and Health Authority audits.
- Oversee complaint handling procedures.
- Manage regulatory submissions.
- Serve as SME for supplier qualification audits.
- Serve as SME for supplier maintenance audits.
- Perform quality assurance for supplier change controls and deviations.
- Facilitate systematic root cause assessments (RCA).
- Coordinate quality support for medical devices and combination products.
- Collaborate with local QA/QC teams on clinical and commercial release.
- Set work priorities for project targets and timelines.
- Maintain up-to-date job-related training status.
- Improve knowledge and skills in quality, compliance, and technology.
- Notify management of potential quality or regulatory issues.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- 21 CFR 820
- EU MDR
- ISO 14971
- Six Sigma
- DMAIC
- Lean tools
- Agile
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche
Industry
Healthcare
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Direct Material Sciences Specialist/Expert(m/w/x)
Full-timeOn-siteExperiencedBasel - Roche
Validation Expert(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - 1201 F. Hoffmann-La Roche AG
Affiliate Network Regional Quality Lead(m/w/x)
Full-timeOn-siteExperiencedBasel - Thermo Fisher Scientific
Operation Investigation Management Specialist(m/w/x)
Full-timeOn-siteExperiencedAllschwil