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To strengthen its organization, Graftys is looking for a “Quality Assurance Manager” (H/F)

February 24th 2020

Founded in 2005 and based on the research works of Pr. Jean-Michel Bouler (CEISAM/CNRS), Graftys develops, manufactures and markets patented synthetic bone biomaterials, in particular new generations of resorbable calcium-phosphate cements, for reconstructive orthopedic surgery. Within the 3 million annual procedures bone graft market, the bone cement market segment is one of the fastest-growing. The Company's key products - Graftys® Quickset fast setting/high viscosity and Graftys® HBS lower viscosity/high injectability cements - are commercialized in more than 25 countries, including Europe and the United States of America, through distribution partnerships. The objective of the Company is to develop its existing activities especially in key markets such as Europe and the USA, to enter new high-potential markets such as Asia (China, Japan...) where the Company is not present yet and expand the Company product lines by offering new versions of existing products and new products with enhanced regenerative properties.

Mission Description

Within a dynamic team, under the supervision of the Site Director, your missions will be articulated as follows:

Contribute to the implementation of a quality assurance system:
• Manage batches disposal activities related to manufacture and testing of medical device to ensure compliance to internal and regulatory requirements,
• Be responsible for Quality Assurance Organization, which consists of the following topics (1. Quality Systems, Metrics, Management Review, Internal/External Audits, Change control,… 2. Training, Documentation Control, Product Lifecycle Management,… 3. Complaints, Recall,…)
• Establish, implement, and maintain an effective, efficient, and cohesive quality system that ensures compliance with FDA, MDSAP and ISO expectations,
• Monitor and report on the performance of the Quality System to Executive Management,
• Organize and lead FDA, MDSAP and Notified Body audits and inspections,
• Identify, drive, and support optimization and harmonization opportunities to increase effectivity and efficiency,
• Ensure partnership with Regulatory to develop, support, and execute compliance related strategies,
• Ensure partnership with production team to ensure quality system enables design and manufacturing success while maintaining compliance,
• Drive Quality Culture and Core Value Behaviors,

Contribute to the continuous improvement of the quality system:
• Identify, drive, and support optimization and harmonization opportunities to increase effectivity and efficiency,
• Develop and drive measurable Quality improvements relating to products and processes,

Candidate profile

  • Scientific degree (PhD in biomedical sciences, biochemistry, pharmacy, life sciences, …),
  • You have at least 5 years of experience in quality assurance in the pharmaceutical industry (in the medical device sector is a plus),
  • Experience with FDA Quality Systems Regulations, ISO 13485, Quality Certificates, GMP, and MDSAP
  • Thorough understanding of medical device industry regulations and quality system design/management,
  • Structured and methodical problem-solving approach,
  • Ability to foster a positive culture of growth, collaboration, and achievement across the organization,
  • Ease to operate in a start-up/biotech environment,
  • Good oral and written communication,
  • Team spirit, rigorous, independent, pro-active and versatile,
  • French and fluent English

Offer

Full-time
Permanent contract (CDI)
Attractive remuneration
Position based in Liège, Wallonia, Belgium

Contact Details

This opportunity to integrate an innovative company motivates you? Do you want to invest in a dynamic and fast-growing company? So do not hesitate to send your detailed CV and cover letter to career@graftys.fr