QMS Software Engineer
Update job description dd 13/6/2018
As Part of the Philips Business Transformation program, we are developing standard Processes and IT solutions for Document Record & Control / Quality Management Systems. To support the Philips Team in the validation execution, we are looking for experienced Document & Record control specialists or validation engineers, who are familiar with Quality Management Systems (ISO 13485), FDA (21CFR) regulations and experience with System Validation.
• Author User Requirements Specifications (URS), test plans, protocols (PQ scripts) , results, risk assessments, traceability matrix and summary reports.
• Reviews Software (SW) Validation deliverables for non-product SW, including but not limited to software validation plans, URS, Functional Requirements Specifications (FRS), risk assessments, traceability matrix and summary reports.
• Execute PQ dry-runs and assist business with PQ execution
We are looking for
Our ideal candidate has the following profile criteria:
• Minimum of 2 years of related experience in Document & Record Control and Change management field
• Minimum of 2 years of experience in Business Quality Management Systems (ISO 13485), FDA (21CFR) regulations and Computer Systems Validation
• Familiarity with Document and Change Management System tools
• 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 Good Documentation Practices experience in medical devices (must have)
• Experience writing test scripts (preferably PQ scripts or OQ scripts)
• Experience writing User Requirements Specifications
• Experience in performing testing (specifically UAT and Performance Qualification)
Start date = as soon as possible
End date = September 30th (Might be extended)
Hours/week = min. 32 hours
Site = Eindhoven Boschdijk (preferably at least 3 days), there is a possibility to work 1 or 2 days from the Amsterdam Office as well.
Max budget senior profile is 73 euro/hr