QMS Software Engineer

Posted Jun 8, 2018
Project ID: PHILJP00017567
Eindhoven , Noord Brabant
4 months (Jun 11, 2018 - Sep 30, 2018)
40 hrs/week
Payrate range
63 - 73 €/hr
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.

Your responsibilities
•  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
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