Description:
QUALITY ASSURANCE OFFICER
Introduction
A forward thinking and innovative medtech company situated in Pretoria is seeking an informed and thorough QA Officer with 3 -5 years’ experience to join their team.
Job purpose:
To assist with maintaining a company-wide quality management system (QMS) as well as assisting with medical device certification(s).
This includes maintaining documentation of specifications and procedures, research and
development, prototyping and keeping up to date with the latest local and international standards.
REQUIREMENTS
Minimum education (essential):
• Diploma in Industrial Engineering, Quality Management
OR
• Relevant Quality Management Certification
Minimum education (desirable):
• BEng (Industrial or similar)
Minimum applicable experience (years):
• 3 years with a Degree or Diploma
OR
• 5 years with a Certification
Required nature of experience:
• Quality Management Systems (ISO 13485, ISO 9001, or similar) and regulated environments
• Requirement gathering and documentation
• Internal audit experience
• Risk Management (ISO 14971)
• Experience in the medical or technology industries would be beneficial
Skills and Knowledge (essential):
• Excellent computer proficiency (especially in MS Office Excel)
• Report and proposal writing skills
• Business process design
• Internal audits
• Quality Management Systems (ISO 13485, ISO 9001, or similar)
Skills and Knowledge (desirable):
• Medical device regulatory (European MDR, UK MDR and US FDA)
• ISO 13485 auditing certification
• Agile Project Management
• BPMN or UML Knowledge
• HIPAA compliance
• POPIA compliance
• GDPR compliance
• Medical Device Software Life Cycle (EN 62304)
KEY PERFORMANCE AREAS, WEIGHTS AND OBJECTIVES
Quality Management 40%
• Define quality procedures in conjunction with operating staff.
• Set up and maintain controls and documentation procedures.
• Conduct internal audits on existing processes.
• Conduct supplier management in line with QMS processes.
• Support in keeping medical device risk files and device literature valuation are up todate.
• Conduct training on the QMS system and associated processes.
• Any other lawful tasks required by management
Regulatory Compliance 30%
• Assist with compliance of medical devices to relevant medical device regulations.
• Conduct post market surveillance activities in line with QMS processes.
• Research and implement when required any new regulatory requirements and compliance related t...