Quality Assurance Officer

Quality Assurance Officer

We are looking for an experienced Quality Assurance Officer in the Menlo Park area (Pretoria East)Requirements:- Relevant Tertiary Qualification in the field of Biotechnology/Biomedical science and Quality- Proven knowledge of ISO 13485- Minimum of 2 years working experience in a Quality related field, preferably in the medical device industry.- Advanced computer and Excel skills- The ability to communicate effectively in English (written and spoken word)Responsibilities:Compliance- Implements, manages, maintains, oversees, administrates, and improves ISO 13485 requirements and the quality management system.- Initiate new SOPs as and when required,





as per company needs.- Ensure that all facets of the organisation comply with ISO 13485.- Ensure that international and national legislation are applied and adhered to.QMS- Ensure that current processes are consistent with established QMS and legal standards.- Ensure that new procedures or any procedure changes are updated to reflect current practice.- Conduct and coordinate internal audits of all facets of the Company to ensure that all SOP and systems are adhered to.- Managing change control through the Quality Management System and ensure that changes are documented and communicated accordingly to all relevant parties.- Managing Risk Management document for the company.- Working with all staff to establish quality requirements for external suppliers.Non-conformances- Ensure that all corrective actions are dealt with accordingly and that they are monitored for statistical purposes.- Ensure that follow up of findings is performed and that corrective actions are sufficient.Quality Control- Ensure that Calibrations of all equipment are carried out timeously.- Ensure that validation activities are carried as and when required.- Obtaining results of process performance from management reports and make recommendations for improvement.- Defining quality procedures in conjunction with operating staff.Continuous Improvement- Consider processes in terms of added value and continually improve processes based on objective measurements per department.- Identify gaps between current and required practice, recommend and drive improvement activities to address the gaps.- Assists to align all Departmental objectives to achieve those mentioned in the Company Policy.

▶️ Quality Assurance Officer
🖊️ Stonebridge HR Solutions
📍 Pretoria