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Quality Assurance Manager (H/F/X)

February 24th 2021

Graftys is an innovation-driven Medtech company committed to the development and manufacturing of synthetic bone biomaterials. Graftys markets products covered by a large patent portfolio in more than 25 countries throughout the world, with regulatory approvals in Europe, the USA, Canada, North and South America and Australia.

Mission Description

Within a dynamic team, under the supervision of the CEO, 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:
- Quality Systems, Metrics, Management Review, Internal/External Audits, Change control, …
- Training, Documentation Control, Product Lifecycle Management, …
- 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

  • Offer
  • Full-time
  • Permanent contract (CDI) of freelance
  • Attractive remuneration
  • Position based in Jumet, Wallonia, Belgium

 

Contact Details

Please contact to career@graftys.fr