Quality Assurance Officer

4 days ago


Johannesburg, South Africa Unique Personnel Full time

**Job Number**

66383

**Job Type**

FT Contract

**Job Title**

Quality Assurance Officer

**Computer Skills**

MS Excel,MS Office,MS PowerPoint,MS Word,ISO 14385

**Industry**

Pharmaceutical - Healthcare

**City**

Johannesburg (Incl. Northern Suburbs)

**Province**

Gauteng

Fixed Term Contract (3 months)

Reporting to Managing Director

Job Purpose:
To ensure that all external and internal quality and regulatory requirements are met to ensure that our products can reach our customers. To oversee the Quality Management System (QMS) and ensure compliance to Medical Device Regulation South Africa (MDR-SA)

Job Responsibilities:

- To ensure that a QMS is developed, implemented and maintained in accordance with 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 the company 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 with regular reviews of MDR-SA and advising the management team on requirements that would be required within the business to remain compliant.

To take the duties of the Quality Management Representative

**Inherent Requirements**

Degree

Minimum of 3 years quality assurance experience. Healthcare industry preferred

Advanced understanding of ISO 14385

Working with MDR-SA is desired

**Skills**:Energetic, self-starter

Sound organisational skills and ability to multi-task

Strong interpersonal relations and ability to build connections globally

Demonstrates numerical acumen

Integrity, initiative and adaptability

Computer literacy; Excel, PowerPoint, Word

Competencies:
Communication - communicates written and oral information concisely and persuasively; communicate own viewpoint succinctly and facilitates discussions to achieve clear outcomes. Excellent presentation skills

Internal and External Stakeholders - develops positive relationships with all stakeholders for the long-term benefit of the business

Drive for results - is pro-active and uses initiative to achieve objectives. Overcomes obstacles to maximise personal contribution. Appropriate plans time to deliver

Knows the business - understands the Quality and Regulatory requirements of a medical device/ healthcare business. Upholds the high standards of working a medical device business including ISO13485 and the MDR-SA. Becomes company Ambassador internally and externally for all matters relating to the quality & regulatory environment.

Planning, organising and prioritising - plans work activities, reviews and prioritises as necessary to achieve high standards and meet deadlines.

Team working - works with others across the organisation to accomplish goals and identify and resolve problems

**What Qualification**

**Minimum Qualification**

Bachelors

**Status**

Available



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