Lead and maintain QMS implementation- CAPA, Complaints etc.
Manage CAPA and Complaints boards and make decisions regarding customer
complaints and changes to the product design, write CAPA root cause investigations
reports.
Perform statistical analysis for CAPA and complaint for management reviews.
Conducts internal audits, preparation for external audits and participation in external
audits by regulatory bodies.
Preparation and participation in management review meetings.
QA representative in risks evaluation for regulatory compliance.
Ensure Quality Systems activities are implemented and maintained to satisfy FDA GMP/QSR,
ISO 13485, MDR, MDSAP and applicable local regulatory requirements.
Manage CAPA and Complaints boards and make decisions regarding customer
complaints and changes to the product design, write CAPA root cause investigations
reports.
Perform statistical analysis for CAPA and complaint for management reviews.
Conducts internal audits, preparation for external audits and participation in external
audits by regulatory bodies.
Preparation and participation in management review meetings.
QA representative in risks evaluation for regulatory compliance.
Ensure Quality Systems activities are implemented and maintained to satisfy FDA GMP/QSR,
ISO 13485, MDR, MDSAP and applicable local regulatory requirements.
Requirements:
Bachelors degree is required.
2-5years of experience in a Quality function within the medical device company.
Knowledge of applicable Quality system regulations, such as GMP/QSR, MDR and ISO 13485.
Very good English skills (speaking, reading, and writing).
Bachelors degree is required.
2-5years of experience in a Quality function within the medical device company.
Knowledge of applicable Quality system regulations, such as GMP/QSR, MDR and ISO 13485.
Very good English skills (speaking, reading, and writing).
This position is open to all candidates.
