Quality Assurance Director

Location Belgium
Discipline: Medical Device
Job type: Permanent
Contact name: Eva Koemar

Contact email: e.koemar@panda-int.com
Job ref: 19442
Published: 16 days ago

For our partner, a fast-growing, innovative and internationally operated medical device manufacturer, we are looking for a Quality Assurance Director. If you are passionate about improving patients’ quality of life, innovating your team’s operational performance and are willing to take ownership of your initiatives, you are the person we are looking for.

You will be based in Belgium (greater Antwerp Area) and as a part of the permanent division, you will lead 6 different entities in the Western EU. As head of the quality department, you will use your meticulousness, analytical skills and excellent communication skills to ensure synergy between these different, multicultural departments.

 

MAIN RESPONSIBILITIES

  • You oversee the QMS performance and drive continuous improvement for both compliance to ISO 13485 & 21CFR 820 and applicable Medical Device regulations and GxP
  • Final responsibility over all quality documentation and reports
  • Drive and lead quality project meetings
  • Provide support to R&D, QA and RA in the company-wide innovation management processes, including projects outside the direct scope of the function
  • Responsible for both product- and business-oriented risk management
  • Lead quality inspections from the authorities and audits from customers
  • Set up and follow up departmental objectives and budgets

 

YOUR QUALIFICATIONS & EXPERIENCE

  • You hold a Bsc or Msc in Pharmaceutical Science or an equivalent field
  • You have 6+ years’ experience in management of a QA department and project leadership
  • Fluent in written and spoken English. Proficiency in Dutch, French and/or German is an asset
  • You hold perfect command of quality processes and procedures
  • You are experienced in product manufacturing and GxP
  • You have strong knowledge of ISO13485, 21 CFR 820 MDR, QMS software
  • You have an ISO/EN auditor certificate or the desire to obtain it
  • An experience of semi-solids manufacturing and/ or Quality Control is an asset

 

ORGANISATION & OFFER

You will be working for a family-owned, diverse medical device company that specializes in wound skin care. You will enjoy working with cutting-edge technologies and will being part of a flexible, enthusiastic organization. They offer Excellent (primary + secondary) working conditions, Innovative and inspiring working environment, Independent project work and responsibilities within a professional team, Career prospects and Competitive renumeration (based on experience).

 

INTERESTED?

Reach out to Eva Koemar for more information by contacting +31 (0)20 20 44 502 or email me at e.koemar@panda-int.com.