QA Medical Device
Real Staffing
Nazareth, Antwerp, BE
1 dag geleden
source : Monster

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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