Do you have Quality Assurance (QA) and/or Regulatory Affairs (RA) experience in the field of development and certification of medical products ? And would you like to work in a dynamic environment with a wide variety of products? Then we are looking for you!

The senior QA/RA lead at Demcon is a challenging position with very diverse work. You work closely with all disciplines within Demcon, but also have contact with external parties. We are looking for someone with a few years of experience in the field of development and certification of medical products.

Our companies each distinguish themselves in their own field with unique expertise and skills. In doing so, they help clients to perform better and achieve more. From a passion for technology, our companies are able to join forces. By sharing knowledge and working together we make more social impact. Demcon advanced mechatronics is a multidisciplinary development and engineering partner for mechatronic challenges, from concept to realization. 

As a QA/RA lead you will be part of the management team of the Life Science and Health Business at Demcon Best. Within this team you will be end-responsible for the QA/RA activities related to the design and development of medical products and bio-technical products. Next to that you also will be responsible for QA/RA activities on business level.

In your role as QA/RA lead you will focus on compliance by:

• Assess product quality in running projects and advice how to improve this.
• Prepare and guide external audits; facilitate and execute internal audits
• Answer/solve complicated RA issues

Next to that, you can also be involved in the following activities:

•  Follow-up of actions and KPI’s that were defined in the management review
• Facilitate and manage CAPA’s (Corrective and Preventative Actions)

Next to the lead activities, you will also work as a QA/RA engineer in multidisciplinary project teams. Within this team you lead the QA/RA activities in related to medical products/medical device software. Typical project activities are:

• Define the regulatory strategy, in close collaboration with our customers.
• Advise the development team with respect to certification of medical products.
• Ensure product safety and proper practices in line with our quality system.
• Define which standards and regulations apply and coordinate these matters with the customer.
• For certification you bring the technical file in order.

• Biomedical technology, health sciences or a technical education. (Master of Science Level)
• At least 5 years of experience as Quality Assurance and/or Regulatory Affairs specialist in the field of development and certification of medical products. Detailed knowledge of the MDR and ISO13485
• You are a team player, who can communicate and interact well at various levels both towards project team and client

At Demcon we value a pleasant workplace. We are happy to provide you with the right tools within a beautiful workplace. In addition, we have delicious coffee and free fresh fruit is available for you every week. There is also a lot of personal attention and we discourage overtime because we know how important home is.

You can also count on:

• A good, competitive salary;
• 31 off days and an 8% holiday allowance;
• A good pension scheme at Zwitserleven;
• Follow courses or even follow courses through the Demcon Academy that you can use to further develop your knowledge;
• A laptop and telephone from work;
• Active staff association (monthly activities such as drinks and an annual Demcon weekend) and annual sporting events.

Do you have any questions about this position? We will be happy to answer them via recruitment@demcon.com.

Have we aroused your interest for the position of QA/RA Lead Engineer. Then we look forward to receiving your cv. You can apply via the application button.

Acquisition based on this advertisement is not appreciated.