Quality Assurance Officer

**Job Purpose**:
To assist with maintaining a company-wide quality management system (QMS) as well as assisting with medical device certification(s), including, but not limited to ISO13485, CE and FDA. This includes maintaining documentation of specifications and procedures, advising the internal team on regulatory and quality issues, and keeping up to date with the latest local and international standards. Ensuring registration and compliance with the relevant authorities/notified bodies.

**Minimum Requirements**:
**Education**
- NQF Level 5+ qualification
- Relevant Quality Management Certification

**Skills and Knowledge**
- Essential
- Quality Management Systems (ISO 13485, ISO 9001, MDR, UKCA) or FDA 510(k)/DeNovo and facility registrations as a minimum.
- Excellent computer proficiency (especially in MS Office Excel)
Report and proposal writing skills
- Business process design
- Internal audits
- GSuite operations (or an equivalent cloud-based document management tool)
- Good communication and reporting skills
- Desirable
- Medical device regulatory (European MDR, UKCAand US FDA)
- ISO 13485 auditing certification
- SAHPRA Compliance & Registrations
- SOC2-Type II experience
- HIPAA compliance
- POPIA compliance
- GDPR compliance
- Medical Device Software Life Cycle (EN 62304)

Experience
- 3 years of Quality Assurance with a Degree or Diploma **_or _**5 years of Quality Assurance with a Certification
- Setup, maintenance and internal audit of Quality Management Systems (ISO 13485, ISO 9001, or similar)
- Regulatory certifications within medical device (and highly regulated) environments
- Requirement gathering and documentation of processes and records management
- Internal audit for QMS
- Risk Management (ISO 14971)
- Experience in the medical or technology industries would be beneficial.

**Key Performance Areas, Weighs, and Objectives**:
**Quality Management**
- Define quality procedures in conjunction with operating staff.
- Drive the development, improvement and implementation of the hearX Quality Policy.
- Set up and maintain controls and documentation procedures.
- Conduct internal audits on existing processes.
- Conduct supplier management and management review meetings in line with QMS processes.
- Support in keeping medical device risk files and device literature valuation are up to date.
- Conduct training on the QMS system and associated processes.
- Manage internal change management to drive adoption of QMS within the company.
- Liaise with internal teams and process owners in order to drive quality management within the company.
- Any other lawful tasks required by management

**Regulatory Compliance**
- Create and maintain facility and product registrations at relevant bodies in active territories.
- Assist with compliance of medical devices to relevant medical device regulations.
- Assist in aligning post market surveillance activities/reports with QMS processes.
- Research and implement (if and when required) any new regulatory requirements and compliance related topics, processes and documentation.
- Compile relevant records as is necessary for compliance to ISO, CE, FDA (and other) standards and requirements as is applicable to all products.
- Compile and disseminate information to relevant employees, training them as necessary on regulatory requirements.
- Communicate with notified bodies regarding quotes, schedules, documentation and audits.
- Support software development requirements for medical device software, where applicable/relevant.
- Provide expert, accurate guidance to stakeholders/top management on regulatory pathways

**Record-Keeping**
- Accomplish objectives by establishing plans and results; reviewing progress and making mid-course corrections to ensure optimal outcomes.
- Maintain documentation and SOPs within the department