Quality Assurance Professional
About the Role
This position involves the implementation and maintenance of a quality management system (QMS) to ensure compliance with applicable regulations and standards.
* Maintain procedures, work instructions, and records for the QMS.
* Ensure timely document control and change management activities.
* Track and report key performance indicators for the QMS.
* Monitor and trend quality metrics.
* Support Corrective and Preventive Actions (CAPA) by conducting investigations and effectiveness checks.
* Collaborate in risk management processes.
* Evaluate the effectiveness of the QMS and improve processes through collaboration.
Required Skills and Qualifications
To be successful in this role, you will require:
* Bachelor's degree in a Science-related discipline.
* Minimum 3–5 years' experience in the Medical Device industry within a Quality Assurance role.
* Strong knowledge of current QMS requirements, particularly ISO 13485.