Bedal is a medical device scale up, developing the best catheter securement devices; these devices ensure safe and secure fixation of catheters that need to remain in the human body for a longer period of time. Today, our products are already helping patients in more than 30 countries globally.
As a fast growing company, we are expanding our line of products by developing multiple new devices, and bringing them to high volume production.
Are you a dedicated Quality Engineer who is excited by our journey and who enjoys working on a range of unique and innovative medical devices from the ideation phase up to the market launch and high volume production?
Are you excited about working on products that will help patients globally and to work in a small team while interacting with global clients and hospitals?
What will you actually do at Bedal?
As a Quality Engineer you are responsible for the management and improvement of the quality management system and the regulatory requirements. You ensure the qualitative aspects of the medical devices and take up this responsibility towards customers, suppliers and official entities. You monitor and improve the procedures in order to guarantee the quality of the devices.
You develop and implement the quality procedures according ISO 13485 and MDD/MDR and other relevant regulatory requirements
You develop deep domain expertise in the regulatory requirements for market approval of medical device products type Class I sterile (CE, FDA, etc).
You support the quality aspects of new product development process (such as: technical file set up, coordination of lab tests, sterilisation validation).
You work on the continuous improvement and development of the quality management system and keeping the quality documentation up to date.
You implement Quality Agreements and change agreements with suppliers.
You participate in quality audits (internally and externally).
You lead complaint investigations and implement corrective and preventive actions.
You maintain the complete documentation of the technical files.
Who are we looking for?
You have a university degree, and a first experience in a quality role.
You have relevant experience in the medical device industry and knowledge of the applicable quality system requirements.
You have the competence to grow in the organization and take up more responsibilities in a management function.
You have an affinity with production and assembly of products.
Excellent communication skills (verbal, written, listening) and interpersonal skills. Ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion.
High level of personal and professional integrity and trustworthiness with strong work ethic.
Quality oriented mindset.
You work in a diligent and structured way.
Hands-on profile, ability to work independently under minimal supervision.
Passion for improving lives of patients, to make a difference, to grow a scale up.
Fluency in English and Dutch is required.
You’re willing to travel occasionally (destinations include EU, US and South America).
Our offer and commitment to you
Young and dynamic work environment in a highly motivated team
The opportunity to play a pivotal role in the success of a medical device scale-up company
A competitive salary
Location: Diepenbeek, in a hybrid work environment