Quality Officer

2 weeks ago


Johannesburg, South Africa HARTMANN Full time

Join our team as a

**Quality Officer**

ZAF-Johannesburg

To oversee the Quality Management System (QMS) and ensure compliance to Medical Device Regulation South Africa (MDR-SA)

**Your area of responsibility**:

- To ensure that a QMS is developed, implemented and maintained in accordance with Paul HARTMANN AG (PHAG) corporate requirements, the MDR-SA and ISO 13486, 2016, which-ever is the most current legislation. The management of the QMS includes complaint procedures, CAPA process, establishing and maintaining standing operating procedures (SOP), work instructions, and other forms and records needed.
- To ensure that PHZA develops a culture of quality and regulatory compliance.
- To identify and escalate compliance gaps observed during internal and external audits and to ensure their completion
- To provide the leadership team of HARTMANN South Africa with regular reviews of MDR-SA and advising the management team on requirements that would be required within the business to remain compliant.

**What we look for**:

- Relevant Diploma/ Degree
- Minimum of 2 year quality assurance experience
- Healthcare / Medical industry preferred
- Advanced understanding of ISO 14385
- Working with MDR-SA is desired


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