Quality Assurance Specialist

For an international company in Heverlee we are looking for a Quality Assurance Specialist.

Main responsibilities:

• Support the implementation, maintenance and improvement of quality systems based on information in the organisation's strategic plan, audits, changes in ISO and the priorities within the organisation
• Participating in or lead teams in supporting quality disciplines, decisions and practices (represent the Quality function as a core team member)
• Support to and review of quality systems processes and improvement of awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities
• Control/audit systems to guarantee compliance and to initiate and/or implement improvement
• Assessment and confirmation of suppliers’ capability to meet standards of supply, through supplier selection, approval and evaluation process
• Ensuring that all procedures relating to the quality, safety and environment system are kept up to date and have them checked regularly by the right people
• Support to continuous improvement activities in terms of process and system improvement
• Providing trainings to all associates on quality related aspects
• Coordinating internal, supplier and external audits
• Ensuring that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
• Implementation, monitoring and maintenance of the NCR/CAPA (Non-Conformity Report – Corrective Action Preventive Action) processes
• Review of validation activities to ensure compliance with regulatory requirements and internal quality standards. This includes assessing validation protocols, test methodologies, and acceptance criteria
• Analysis of data reported in validation reports, identifying trends, deviations, and potential risks
• Providing analysis to confirm the reliability and accuracy of validation outcomes, ensuring that processes, equipment, and systems meet predetermined quality and performance specifications
• Implementation, monitoring and maintenance of the complaint handling processes

Interested? Apply today and we will contact you! 

• University degree of Engineering, Chemistry, Dentistry or equivalent life science degree
• Minimum 2 years of experience in the Medical device / Pharma / Life science industry
• Solid understanding of mandatory legal and regulatory documents
• Deep knowledge of ISO Standards (13485, 9001)
• Practical knowledge of EU Medical Device Regulation, and relevant guidelines
• Knowledge of quality tools and methods
• Result and quality-oriented approach, customer focus, analytical thinking, good communication skills, highly committed personality are required competencies
• Very good command of MS Office applications (Excel, PowerPoint, Word)

• Challenging job in a growing international company
• Multicultural working environment
• Full time employment with a contract for indefinite period
• Flexible working hours and possibility to work from home
• Competitive salary including benefits (meal vouchers, hospitalization and group insurance)