SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperienced
Tolochenaz, Lausanne
from CHF 144,000 / year
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SMSMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
Tolochenaz
from CHF 92,000 - 138,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- MDSAP
- FDA
- Notified Bodies
- Design History File (DHF)
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SMO Medtronic Europe Sàrl 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.
Not a perfect match?
- SMO Medtronic Europe Sàrl
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Associate Calibration Engineer(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 123,480 / year - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Full-timeOn-siteJuniorLausannefrom CHF 123,480 / year
SMSMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
Tolochenaz
from CHF 92,000 - 138,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- MDSAP
- FDA
- Notified Bodies
- Design History File (DHF)
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SMO Medtronic Europe Sàrl 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
SMO Medtronic Europe Sàrl
Industry
Healthcare
Description
The company leads global healthcare technology and addresses challenging health problems through innovative solutions.
Not a perfect match?
- SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedTolochenaz, Lausannefrom CHF 144,000 / year - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 144,000 / year - SICPA SA
Operational Quality Engineer(m/w/x)
Full-timeOn-siteSeniorPrilly - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 123,480 / year - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Full-timeOn-siteJuniorLausannefrom CHF 123,480 / year