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Change Control Specialist(m/w/x)
Managing manufacturing process documentation and part specifications for implantable blood pump systems. 3-6 years experience in MedTech or Pharma engineering environments required. Small team context with high-precision technical writing focus.
Requirements
- Understanding of MedTech/Pharma environment
- Good communication skills
- Independent problem-solving mindset
- Technical degree in technical/scientific fields
- 3-6 years experience in Engineering, Quality, or Technical Writing
- Experience with medical device manufacturing
- Good written and oral English skills
- German speaking an advantage
- Experience with PLM and ERP software
- Familiarity with IT data services
Tasks
- Support the process engineering team
- Create and edit manufacturing process documentation
- Manage part specifications and inspection procedures
- Maintain design and project documentation
- Ensure documents are properly traced and approved
- Reflect product and process changes in documentation
- Modify documentation using PLM and ERP software
- Collaborate with R&D and Quality departments
- Ensure document compliance with Quality templates
- Follow global regulatory requirements and instructions
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- PLM
- ERP
- Windchill
- SAP
Benefits
Diverse Work
- Challenging position
Startup Environment
- Young, dynamic, skilled team
Informal Culture
- Flat hierarchies
- Open appreciative mentality
- Efficient, constructive communication
- Multi-national environment
Learning & Development
- Talent development
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Change Control Specialist(m/w/x)
Managing manufacturing process documentation and part specifications for implantable blood pump systems. 3-6 years experience in MedTech or Pharma engineering environments required. Small team context with high-precision technical writing focus.
Requirements
- Understanding of MedTech/Pharma environment
- Good communication skills
- Independent problem-solving mindset
- Technical degree in technical/scientific fields
- 3-6 years experience in Engineering, Quality, or Technical Writing
- Experience with medical device manufacturing
- Good written and oral English skills
- German speaking an advantage
- Experience with PLM and ERP software
- Familiarity with IT data services
Tasks
- Support the process engineering team
- Create and edit manufacturing process documentation
- Manage part specifications and inspection procedures
- Maintain design and project documentation
- Ensure documents are properly traced and approved
- Reflect product and process changes in documentation
- Modify documentation using PLM and ERP software
- Collaborate with R&D and Quality departments
- Ensure document compliance with Quality templates
- Follow global regulatory requirements and instructions
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- PLM
- ERP
- Windchill
- SAP
Benefits
Diverse Work
- Challenging position
Startup Environment
- Young, dynamic, skilled team
Informal Culture
- Flat hierarchies
- Open appreciative mentality
- Efficient, constructive communication
- Multi-national environment
Learning & Development
- Talent development
About the Company
ThoratecSwitzerland GmbH
Industry
Healthcare
Description
ThoratecSwitzerland GmbH is a global market leader in implantable and extracorporeal blood pump systems, developing and producing lifesaving medical devices for severe heart disease.
Not a perfect match?
- Abbott Laboratories GmbH
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Test Engineer - Medical Device(m/w/x)
Full-timeOn-siteExperiencedZürich - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Full-timeOn-siteSeniorSchlieren - Tecan Trading AG
Technical Writer(m/w/x)
Full-timeOn-siteExperiencedMännedorf