Quality Engineer Medical Devices
Onera Health
- Eindhoven, Noord-Brabant
- Vast
- Voltijds
- 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
- 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)
- 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