Quality Assurance Officer

7 months ago

Pretoria, South Africa Green Marble Recruitment Consultants Full time

Precision meets perfection My client is in pursuit of a meticulous Quality Assurance Officer to safeguard the highest standards in the dynamic world of medical devices. If you have an eagle eye for detail, a commitment to compliance, and a passion for ensuring every product adheres to the most rigorous quality benchmarks, then this is your moment to shape the future of healthcare technology. Join them in the critical mission of delivering excellence and reliability in every heartbeat of our medical devices

**Minimum Requirement**
- Certificate or higher in health sciences, biomedical technology, business administration, or equivalent qualification.
- Certificate (desirable)
- ISO 13485* certificate.
- ISO 13485* internal auditor certificate.
- ISO 14971* certificate.
- IEC 62304 certificate.
- Min of 3 years’ experience with quality management.
- Min 1 year of developing and implementing a Quality Management System according to ISO 13485.
- Knowledge of ISO 13485, MDR, UKCA or, FDA.
- Excellent computer proficiency (MS Office or GSuite).
- Report and proposal writing skills.
- Business process design.
- Internal audits (knowledge essential).
- GSuite operations (or an equivalent cloud-based document management tool).
- Good communication and reporting skills.
- Self-driven, self-organized, and problem-solving oriented.

**Responsibilities**

**Quality Management**
- Define quality procedures in conjunction with operating staff.
- Drive the development, improvement, and implementation of the company Quality Policy and Quality Management System.
- Set up and maintain controls and documentation procedures.
- Conduct internal audits on existing processes (if applicable)
- Assist with supplier management in line with QMS processes.
- Collaborate and assist with management review meetings in line with QMS processes.
- Support in keeping medical device risk files and device literature valuation up to date.
- Conduct training (formal or informal) on the QMS system and associated processes.
- Manage internal change management to drive the adoption of QMS within the company.
- Liaise with internal teams and process owners to drive quality management within the company.
- Any other lawful tasks required by management.

**Regulatory Compliance**
- Assist in maintaining 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 and reports with QMS processes.
- Research and implement (when required) any new regulatory requirements and compliance-related topics, processes, and documentation.
- Compile relevant records as 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.
- Assist in communicating with notified bodies regarding quotes, schedules, documentation, and audits.
- Support software development requirements for medical device software, where applicable and relevant.
- Provide expert, accurate guidance to stakeholders/top management on regulatory pathways.
- Accomplish objectives by establishing plans and results; reviewing progress and making mid-course corrections to ensure optimal outcomes.

**Record - Keeping**
- Assist and maintain documentation, SOPs, and records within the various departments.

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