Q&A Officer
At Topic Embedded Systems (Full-time), in Eindhoven, Netherlands
Expires at: 2019-12-03
As an enthusiastic and process driven Quality Officer you will support the (combined) software- and hardware development projects. You are the eyes and the ears of the project with respect to adherence to the Quality Management System (QMS). You will report to the QA Manager on the process quality of the project including possible non-compliance's. You are also the (independent) sparring partner of the Project Manager and help him/her managing the project according the QM. Besides that you will help the project members in using the QMS in a correct way. You will collect improvement suggestions from the project in order to make the QMS more effective and efficient. You will be reviewing all plans and reports from the project and provide input for project milestone reviews.
The Quality Officer supports the QA manager by performing internal audits in the organization and participate in external audits performed by the notified body.
Main responsibilities:
• Regular process quality reporting of the project to the QA manager;
• Peer review of project deliverables such as project plans and test report;
• Compliance check as input for the milestone review;
• Contribution to continuous improvement of the QMS;
• Support account managers, project managers and project members in using the QMS
• Internal auditor to verify compliance of Topic with the QMS.
Main requirements • Finished Bachelor or Master study;
• Preferred experience in a similar role for at least 2 years;
• Used to a dynamic and international working environment;
• Experience in high tech projects;
• Experience with software- and hardware development;
• Knowledge of process standards such as ISO13485, ISO14971, IEC62304 are a plus;
• Knowledge of regulations such as FDA 21CFR80, Medical Device Directive are a plus;
• Excellent knowledge of Microsoft applications such as MS-Word and MS-Excel;
• Fluent English;
• Analytical, strong communication skills and a strong personality; Convincing.
Perks • Interesting, challenging and complex projects;
• An ambitious work environment at our amazing office in Best;
• Plenty of room for development, both technically and personally;
• Good coaching by your Business Manger and QA manager;
• An excellent salary with a first class benefits package such as 13th month, company car etc.;
• Informal and amicable atmosphere;
• Our own gym and fresh fruit;
• 150+ world class colleague
Apply for this position
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