Quality Assurance and Regulatory Affairs (QARA) Officer

BACK In light of our further growth and professionalization we are looking for an

Manage quality tasks including change control, batch release and process validation
Participate in quality related investigations to resolve production, audit, and customer issues
Create, approve, and maintain the Standard Operating Procedures (SOP) and ongoing management of the Document Control System
Organize and facilitate product and process risk assessments
Provide training and support to other departments on procedures and core processes
Report and follow up on quality key performance indicators in a timely manner
Maintain the electronic document management system
Execute internal and supplier audits and support external audits
Ensure all applicable standards are met in relation to regulatory and customer requirements
Identify and support quality process improvements
Ensure registration and approval of medical device with regulatory agencies

Bachelor's or master's degree in science, Biology or Chemistry or equivalent combination of education and experience
At least 3 years of experience as a Quality Assurance Officer in a product development manufacturing environment, preferably in the in-vitro diagnostics industry
Excellent language skills in English is a requirement › Knowledge and practical application of Quality Management System ISO 13485 and In-Vitro Diagnostics Regulation (EU) 2017/746‎ is a must
Advanced critical thinking and organizing skills
Self-starter and ability to work independently
Excellent communication and relationship management skills
Team player with a hands-on mentality
Preferably living in (a radius of 50 km around) Wageningen/Ede

Join a great team of enthusiastic, international, and highly educated professionals in a startup environment
An efficient organization with a focus on innovation and clear lines of communication
Diverse range of activities with ample room for initiative
Opportunity for professional growth alongside the company
Competitive working conditions and benefits
Direct reporting to the COO