Onera is hiring a Quality Manager to help bring safe, reliable, and high-quality medical device products to the EU and US markets. In this role, you will be involved in medical device compliance activities throughout the whole lifetime of our products. As part of a multidisciplinary, young, startup team, you will have great opportunities for personal and professional growth.
Onera is a spin-off company of IMEC & Holst Centre, the world leading research center in nanoelectronics and digital technology. Onera’s ambition is to bring innovative medical devices to the market that will help improve the health and quality of life of patients around the world. Onera is currently developing its first product for the sleep market.
You will be part of a multidisciplinary, energetic, young, and international start-up team. You will help to ensure that our products are in compliance with applicable medical device regulations and with our Quality Management System.
• Establish and maintain Onera’s Quality Management System (QMS)
• Establish and maintain the Quality policies
• Liaise with other managers and the Onera team, provide training, tools and techniques to enable others to achieve the quality objectives
• Follow-up and handling of Corrective and Preventive Actions (CAPAs) and QMS improvement opportunities
• Support internal and external audits
• Work with procurement staff to establish quality requirements/control for external suppliers
• Work with manufacturing staff to ensure that the manufacturing/production processes meet the quality standards
• Ensure good documentation practice
• BSc or MSc in life sciences, engineering or similar
• At least 4 years of relevant work experience
• At least 1 years in the medical device industry in quality assurance preferred
• Knowledge of ISO13485, 21 CFR 820
• Structured thinking, autonomous and ability to prioritize
• Skilled in numerical and statistical analysis
• Attention to detail
• Enjoy a dynamic, diverse, and flexible work environment
• Legally authorized to work in the Netherlands (already possessing a visa/EU residence permit)
• Good communication skills in English (written and spoken)
• Positive attitude, can-do mentality, and flexibility – much needed in a startup!
If you are interested, please contact us by email:
Torenallee 42-54 (Strijp-S), Eindhoven, Netherlands.