Founded in 2005, Graftys develops, manufactures and markets patented synthetic bone biomaterials for reconstructive orthopedic surgery. Graftys is specialized in new generations of resorbable calcium-phosphate cements and is based on the research works of Pr. Jean-Michel Bouler (CEISAM/CNRS).
The Company’s key products are commercialized in more than 25 countries, including Europe and the USA, through distribution partnerships. The objective of Graftys is to expand the company product lines by offering new versions of existing products and new products with enhanced regenerative properties.
Graftys, one of the world leaders in resorbable bone cements, is based in Belgium and France. For more information about the company, please visit https://www.graftys.com
In order to support the expansion of the dynamic team in Liège, we are looking for a (m/f):
Quality Assurance Manager
As a Quality Assurance Manager, you contribute to the implementation of a quality assurance system. Reporting to the Site Director, you establish, implement and maintain an efficient and cohesive quality management system that ensures compliance with the ISO, FDA & MDSAP requirements
Your main responsibilities are:
- You manage batches activities related to manufacture and testing of medical device in order to ensure compliance with internal and regulatory requirements.
- You are responsible for quality assurance organization, which consists in:
- Quality Systems, Metrics, Management Review, Internal/External Audits, Change Controls, …
- Training, Documentation Control, Product Lifecycle Management, …
- Complaints, Recall…
- You monitor and report the performance of the quality management system to the Executive Management.
- You ensure partnership with Regulatory team in order to develop, support and execute compliance related strategies.
- You closely collaborate with Production team in order to ensure quality system enables design and manufacturing success while maintaining compliance.
- You contribute to the continuous improvement of the quality management system.
- You hold a Master’s in Industrial Pharmacy, or a PhD in biomedical sciences, biochemistry, life sciences, etc.
- You are ideally QP registered.
- You have at least 5 years’ experience in production in the life sciences, ideally in the medical device industry.
- You have experience with FDA Quality Systems Regulations, ISO 13485:2016, Quality Certificates and MDSAP.
- You are able to foster a positive culture of growth, collaboration, and achievement across the organization.
- You are rigorous, independent, pro-active and versatile.
- You are a team player with a good oral and written communication.
- You are fluent in French and English.
- A challenging and rewarding position within a fast-growing company.
- The opportunity to join a company specialized in innovative products for reconstructive orthopedic surgery.
- To work in a human-sized, innovative, collaborative and dynamic company.
- An attractive salary package in line with your experience.