The Quality Systems Engineer II is responsible to support the corporate quality oversight over general QMS requirements, developing of quality strategy, policies, processes, standards, and systems for the company. Accountabilities • Driving quality system compliance, developing and improving Quality Systems processes, procedures and tools; • Introduce and maintain the Biocartis Enterprise Quality Management System (EQMS) application in a validated state; • Managing and administering User Accounts, user roles and permissions within the EQMS • Acting as the System Administrator for the Biocartis Enterprise Quality Management System (EQMS) application; • Developing and delivering training for the EQMS application, the Training process, the Document Control process and the Record Control process; • Take up the role of Training Coordinator in the EQMS; • Establishing and maintaining the secured records archive for authentic documentation (take up the role of Archive Coordinator); • Developing and implementing optimizations of the Biocartis Enterprise Quality Management System (EQMS), in collaboration with the external application and support provider; • Coordinate and execute the roll-out of changes in the Biocartis EQMS application; • Maintaining, monitoring and improving the Training process, the Document Control process and Record Control process; • Responsible for maintaining, monitoring and improving the Quality Event and Change Control (CR) processes; • Organizing and providing training of personnel in relation to management of Quality Events and Change Requests; • Coordinate the follow-up of Quality Events and CRs in close collaboration with all departments involved, to assure a timely mitigation of deficiencies by responsible functions/persons and escalating concerns as required; • Coordinating the Change Control Process (take up the role of CR Coordinator); • Analyzing performance of Quality System processes (Training, Document Control, Record Control, Event handling, CR, (internal/external) Audit, Software Validation) and providing KPIs for Quality Review meetings; • Responsible for execution & reporting of NCR recurrence analysis; • Take up the role of Quality Review Meeting (QRM) Coordinator; • Establishing and maintaining Baseline Monitoring of QMS processes, as part of the Process Performance Monitoring (PPM) process; • Taking up the role of Internal Auditor; • Establishing of the yearly internal audit plan, follow-up of the execution and report completion; • Preparing for ISO audits, partner audits and FDA inspection readiness by effective interaction with other stakeholders; • Participate in audits performed by external parties; • Responsible for maintaining the ISO supplier certificates in the EQMS; • Participate in the standards/guidance management: purchase standards, upload standards on the appropriate location and update the Standards Library and inform the relevant stakeholders. Profile requirements Bachelor level in science (biomedical/pharma/biochemical/biotechnology) is required or equivalent through experience. Or a Master’s degree or PhD in bio-engineering, chemical engineering, biomedical science, industrial pharmacy would be an asset. At least 5 years of experience in the function of Quality Engineer, Quality Control Engineer or Production Engineer in an: - IVD Medical Device manufacturing environment or -pharma environment or equivalent by experience. Applied knowledge of Good Documentation Practices / Good Manufacturing Practices. Good applied knowledge of procedures/work instructions in a strongly regulated industry (medical devices, pharma); Hands-on experience with a QMS system; Experience in participating in deviation investigations, determining root cause, and Developing corrective action plans is an asset; Customer focused; Very accurate and have an eye for detail; Excellent organization and prioritization skills, and able to adapt to changing priorities; Decision making skills from a quality / compliance perspective; Positive mindset and drive; Technical writing skills; Presentation skills; Familiar with electronic document/quality event management systems; Good analytical and conceptual thinking skills with the ability to solve key problems; Knowledge of QMS regulations and the different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, …); Familiar with Good Manufacturing and Documentation Practices (GMP, GDP). Advanced MS Office skills (in particular Word, Excel & PowerPoint); Excellent communicator, verbally and in writing; Able to work in team and influence others. Advanced knowledge, orally and in writing, of Dutch and English Interested ? our offering We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. We offer you a market competitive compensation package which includes a Flexible Income Plan. We also pay attention to the Wellbeing of our Employees.