QMS Software Engineer
As Part of the Business Transformation program, we are developing standard Processes and IT solutions for complaint handing and Document Control. Since these are critical, and regulated processes, it is essential we validate these processes and IT solutions according applicable standards and regulations. To help/support the Team in the validation execution, we are looking for experienced (validation) engineers, who are familiar with Software Validation, writing & execution of test scripts, specifically performance qualifications / Testing against user requirements.
• GAMP5 / validation knowledge, experience with the type of verbiage to be used in describing test actions, expected results and actual results in scripts executions is required
• Need to have the Preciseness and authoring consistency of an experienced tester, hands on experience with good documentation practices and verbiage used in validation cycles in general
• Need to be able to learn how the business process is supported by an application
• Strong in Good Documentation Practices: Able to write /execute test scripts.
- Location/Timezone preferable NL (or CET), second option in USA (EST, not PT). If NL, being able to visit Eindhoven once a week is preferred, rest is fine working remotely.
must have items:
- good Documentation Practices experience in medical devices, Experience in software validation, script writing and execution.
reason for hire:
- there is a project that requires temporary additional support
Max budget senior person = 95 euro