Quality Engineer Medical Devices
Onera Health, Netherlands
Job Description
Onera is hiring a Quality Engineer Medical Devices 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 lifecycle of our products. As part of a multidisciplinary, dynamic, scale-up team, you will have great opportunities for personal and professional growth. The role is based in Eindhoven, The Netherlands.
The Company
Onera is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments, while also impacting other medical fields by monitoring a variety of chronic conditions, ultimately improving the health and quality of life for patients around the world. The company’s innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs.
Key Responsibilities What You’ll Do
As an integral part of the Quality and Regulatory team, you will help to ensure our processes are kept up to date and lean, and in compliance to our Quality Management System and to the latest regulatory requirements for medical devices.
Your day-to-day activities will include among others:
- Establish and maintain the Quality Management System of Onera and its affiliates
- Liaise with the Onera team, provide training, tools and techniques to enable others to achieve the quality objectives
- Supporting the design and development teams to ensure that Onera products and processes comply with the medical device regulations (CE, FDA)
- Collaborating with procurement to establish quality requirements/control for suppliers
- Working with manufacturing to ensure that the manufacturing/production processes meet the quality standards, both internally and externally.
- Collaborating with our service delivery team to ensure compliance and quality throughout the entire service delivery chain.
- Ensuring good documentation practice
- Keep up to date with national and international legislation, guidelines and best practices.
- Supporting internal and external audits
- Following-up and handling of Corrective and Preventive Actions and improvement opportunities
- Identifying gaps in process workflows or quality issues, determining the root cause and proposing changes
- Playing an active role in defining and improving processes as part of a team
Requirements
In order to be successful in this role you should have:
- A BSc or MSc in life sciences, engineering or similar
- Minimal 3-5 years of work experience with active medical devices
- Knowledge of ISO13485, IEC62304
- Knowledge of 21 CFR 820, MDR 2017/745
- Knowledge of HIPAA, GDPR is a pre
- Preferably experience within an electronic quality management system
- Ability to prioritize, work autonomously and have a structured approach to problem solving
- Skilled in numerical and statistical analysis
- Ability to take initiative and follow through with tasks
- Excellent communication skills in English (written and spoken)
- Positive attitude, can-do mentality, and flexibility
- Legally authorized to work in the Netherlands (already possessing a visa/EU residence permit)
Benefits
- A hybrid / flexible work environment both office and home based
- Technical equipment to set up at home office
- An open and positive company culture, with a lot of team activities
- A competitive salary including a 13th month, participation in pension scheme and Onera stock options
- A holiday package with 25 days and the option to buy additional days