Senior Auditor - Medical Device Quality Systems

Job description

As our Senior Auditor - Medical Device Quality Systems, you will report to the VP Quality and Regulatory Affairs.

You will:

  • lead internal and supplier audit programs for the business and you are a key influencer in the quality systems of the whole organization. This includes the preparation of audit schedules / plans and the creation of a detailed supplier assessment program in combination with operational and R&D goals.
  • audit suppliers. This includes contractors, sub-contractors, suppliers of service as well as suppliers of parts/materials
  • manage the internal audit schedule, plan vendor management and report to management of key quality metrics
  • train internal auditors and build towards the creation of a cross-functional audit team
  • be a key leader within the quality and regulatory team. This includes working on quality strategy, failure investigation, product performance analysis, validations, etc
  • collaborate on the creation of corrective action plans, with the auditee, when audits highlight opportunities for improvement
  • need to make sure that all relevant data collection, analysis and review activities are carried out to a high standard and can be both audited and defended
  • need to make sure that all activities meet the requirements of ISO 13485 and 21 CFR 820

Job requirements

  • You obtained a master's degree / Ph.D. in a scientific discipline and have at least 4 years of relevant experience
  • You have a prior Quality experience in the IVD or medical device industry
  • You are able to take the leadership in terms of Quality Systems
  • Knowledge of the Quality Systems standards / regulations (ISO 13485, 21 CFR 820)
  • You are familiar with a variety of the statistical concepts and practices
  • You are able to create technical reports, business correspondence, technical procedures, as well as administrative procedures
  • You have the ability to represent the team in frequent cross-functional interactions with regulators, subcontractors and/or vendors
  • Ethical attitude and high integrity
  • You are fluent in English. Knowledge of Dutch or French is an asset
  • You are able to travel internationally if required (approx. 10% of your time)
  • Our offices are located in Leuven (Belgium). Relocation to Belgium is needed