Quality Engineer Medical Devices

Onera Health

Eindhoven, Netherlands

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.

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).