They managed to build a high performance, customer-focused organization which today is directly active in 36 countries, serving a high potential market of prescription-free, consumer-oriented health products. A rapidly expanding company constantly looking for dynamic people who are not afraid of a challenge.
Role DescriptionIn order to support the Global Quality Assurance Medical Devices team in maintaining a high-performance QA structure we are currently looking for a Global Quality Assurance Manager / Senior Associate Medical Devices. The management of all medical devices in Europe is centralized at the office in Belgium, Nazareth.
Responsibilities• Provide support in establishing compliance with the Medical Device Regulation in the quality management system at corporate level and with distributors, including the affiliates in Europe. • Provide support in establishing and maintaining the ISO13485 quality management system. • Identify gaps and areas for improvement in QA processes and lead remedial actions and initiatives, including the creation of procedures. • Identify training needs and organize trainings to meet the quality standards. • Support with internal QA audits and customer audits. • Provide input for analysis of data and/or management review meeting. • Support in ensuring ongoing inspection readiness in your area of responsibilities.
Requirements• Master degree in sciences (pharmaceutical sciences, engineering, biochemistry, chemistry …) or equivalent through experience. • At least 2-3 years relevant experience in QA in the medical devices industry. • Good knowledge of the medical devices regulatory environment (Medical device directive 93/42/EEC, MDR). • Knowledge of and experience in ISO13485. • Self-starter, capable of working autonomously at corporate level. • Clear communicator, practical and solution orientated. • Enthusiastic and "get the job done" mindset. • Strong project management skills • Team worker in a multicultural environment. • Fluent in English.
Other information• A key QA position in a growing organization. • An appealing international career opportunity in a dynamic, strong growing multinational company environment. • Apart from a competitive remuneration pack (including pension plan, hospitalisation insurance,…), we offer you excellent personal development and growth opportunities.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.