Medical device company
responsibilities:
• administration of the qms
• review and storage of dhrs
•programming of internal audits and coordination of external audits
• iso 13485 certification manager
•document control, tracking the creation of new documents, revision changes and obsoletes
•maintain quality system documentation and records to ensure traceability, integrity, and accessibility in compliance with corporate policies, regulatory requirements, and customer requirements.
•participate in internal audit and continuous improvement projects.
•responsible for coordinating and conducting supplier audits.
reresponsible for the 8s program.
requirements:
· a diploma or bachelor’s degree in quality or engineering
· at least 3 years of work experience in a quality assurance role in a medical device manufacturing in a cleanroom environment. Molding industry experience is preferred.
· familiar with gmp, iso 9001 and iso 13485.
· knowledge of gmp, clean room controlling and medical devices
· proficiency in english 80%