As our “Lead Quality Systems” you will give direction to the implementation and maintenance of quality systems of the whole organization and run internal and supplier audit programs for the business.

Auditing of suppliers includes contractors, sub-contractors, suppliers of service as well as suppliers of parts/ materials.

You will also manage the key quality system activities, including QS architecture, internal audit schedule, plan vendor management, and report to management the key quality metrics.

You will train internal auditors and build towards the creation of a cross-functional internal audit team. You are a key leader within the quality and regulatory team. This includes working on quality strategy, failure investigation, product performance analysis, validations.

When audits highlight opportunities for improvement, the audit team collaborates on the creation of corrective action plans with the auditee.

You will 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.

All activities meet the requirements of ISO 13485 and 21 CFR 820, and the “Quality System Lead” is a champion of Design controls and data quality.

You will be reporting to our VP Quality and Regulatory Affairs.

• 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 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
• You’re entitled to live and work in Belgium
• You feel comfortable in a start-up environment and you can easily switch from one task to another
• You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues