Job Opportunities 1
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Quality Assurance and Regulatory Affairs (QARA) Officer
Bachelor's or master's degree
32
Dutch/English
Wageningen / Ede (50 km radius)
Main responsibilities
- 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
