Real Staffing

QA Medical Device

Location: Nazareth, Flanders, Belgium
Salary: Up to £5000 per annum + x
Job Type: Permanent
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  • Act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Corporate & Country QA group.
  • Be the QA representative within certain product categories and be responsible for all QA matters associated with these.
  • Agree Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
  • Assist with due diligence and integration of new product developments / new product introductions for assigned categories.
  • Support technical transfers, qualification and validation work.
  • Investigate quality incidents, deviations and complaints, identify and follow-up CAPA's and supplier improvement plans together with third-party contract manufacturers.
  • Evaluate and follow-up Change Controls together with the Regulatory Affairs team.
  • Agree stability programs and review stability results.
  • Contribute to Supplier Qualification and Regular Supplier Auditing.
  • Occasionally provide QA training to the entire group regarding QA systems and processes and procedures and evaluate training effectiveness.
  • Maintain databases and documents according to good documentation practices and record retention procedure.
  • Support in the maintenance of the Quality Management System as SME.
  • Support the internal QA audits.
  • Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
  • Support QA in data and document collection for regulatory purposes.
  • Support QA in ensuring ongoing inspection readiness in your area of responsibilities.

  • Masters' Degree in pharmaceutical or biomedical sciences, engineering, biochemistry, chemistry, or other related subjects, or equivalent through experience.
  • 3 years relevant experience in Quality Assurance / Production.
  • EU Medical Device Directive/EU Medical Device Regulation & other regulatory requirements for medical devices.
  • Knowledge of and experience in ISO13485, ISO14971 and other harmonized standards.
  • Knowledge of manufacturing processes of solid, semi-solid and liquid formulations.
  • You speak and write fluently English. Other languages are an asset.

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