Quality Officer (inhouse position at our Best office)
TOPIC Embedded Systems is the trusted and certified development partner for products or “products-to-be”. With our growing team of 150 employees we specialize in system development in which embedded software and digital hardware are key. We apply our expertise from the very first idea, through design and development to manufacturing and the introduction on the market. The quality of our work and processes are certified by the international ISO13485 standard. We are proud of the many long-lasting relations we have built with our customers. We help them expand their market and together we make the world a little better, smarter and healthier every day.
For TOPIC Embedded Projects in Best we are looking for a Quality Officer
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.
fulltime, Quality, Projectmanagement, QMS
- Locatie Noord-Brabant
What are your responsibilities as a Quality Officer?
• 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.
Who are you as a Quality Officer?
• 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 pré;
• Knowledge of regulations such as FDA 21CFR80, Medical Device Directive are a pré;
• Excellent knowledge of Microsoft applications such as MS-Word and MS-Excel;
• Fluent English;
• Analytical, strong communication skills and a strong personality; Convincing.
TOPIC offers you an employment contract for an indefinite period and....
• 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 colleagues.