For a rapidly growing scale-up active in the medical devices industry, we are looking for a Senior Quality Engineer with a proven track record in the Med Tech industry. The organisation develops and produces innovative and life changing electronic medical devices, with the goal to give people more time to enjoy life, and be a company where people can rely on. Currently, the organisation experiences tremendous growth, and is expected to become a global leader in the near future. At the moment, about 100 employees work at the organisation, which mainly consist of talented and ambitious professionals who believe in a work hard/play hard approach. You will be part of the quality department which now consists of 15 employees, and reporting directly to the Vice President Quality and Regulatory.
As a Senior Quality Engineer, you are responsible for maintaining the ISO 13485 quality management system and ensuring that CAPAs, nonconformities, change controls, product complaints, audits and management reviews are executed conform documented processes. The organisation is expected to tenfold their production next year, and therefore you will be assigned as quality lead in projects in manufacturing and engineering. Next to that, you are expected to ensure that quality KPIs are maintained and communicated on a weekly, monthly and quarterly basis. Besides, you will work closely with cross-functional departments such as scientific support, pricing, customer service, sales, business operations, and supply chain in resolving and investigating product and service complaints.
The organisation can offer you the following:
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Consultant | Medical Devices