Engineering Compliance and CSV Manager at xing
munich, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

23 Nov, 26

Salary

0.0

Posted On

25 Aug, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description
  • Own the computer system validation and process validation processes for the AMBOSS medical device portfolio — procedures, templates and work instructions — keeping them aligned with MDR and ISO 13485 and updated based on audit findings and team feedback.
  • Maintain the inventory of systems in scope and decide, risk-based, which need validation and to what depth; plan, execute and document that validation and keep systems in a validated state as they change.
  • Concentrate validation effort where the evidence is produced — test management, defect tracking, build/release tooling and automated pipeline steps whose outpu


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Responsibilities
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