Quality Assurance Specialist

il y a 5 jours

Leuven, Flandre, Belgique GC Europe Temps plein

GC Corporation was founded in 1921 in Japan and has developed itself into one of the most prominent companies in the development, production and distribution of a very wide range of dental products. Since 1972 GC Europe NV, our European Headquarter is located at the Researchpark Haasrode in Leuven (Belgium). GC Europe NV supports and leads our different sales offices and dealers. Our warehouse spreads our products to Europe and the Middle East.

We are currently 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)
  • Supports and reviews quality systems processes and serves to improve 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
  • Assesses and confirms suppliers' capability to meet standards of supply, through supplier selection, approval and evaluation process
  • Ensure 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 continuous improvement activities in terms of process and system improvement
  • Provide trainings to all associates on quality related aspects
  • Coordinating internal, supplier and external audits
  • Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
  • Implement, monitor and maintain the NCR/CAPA (Non-Conformity Report – Corrective Action Preventive Action) processes
  • Review validation activities to ensure compliance with regulatory requirements and internal quality standards. This includes assessing validation protocols, test methodologies, and acceptance criteria
  • Interpret data reported in validation reports, identifying trends, deviations, and potential risks
  • Provide analysis to confirm the reliability and accuracy of validation outcomes, ensuring that processes, equipment, and systems meet predetermined quality and performance specifications
  • Implement, monitor and maintain the complaint handling processes

Requirements:

  • 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 on 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)
  • Excellent command of both written and spoken English, Dutch is a plus

We Offer you:

  • 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)

Interested?

Send us your CV and motivational letter

GC is an equal opportunity employer that evaluates applicants regardless of their race, nationality, gender, age or disability.

We welcome candidates from all backgrounds, and actively promote diversity in the workforce.

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