Quality Assurance Officer
3 days ago
We are looking for an experienced Quality Assurance Officer in the Menlo Park area (Pretoria East)
**Requirements**:
- Relevant Tertiary Qualification in the field of Biotechnology/Biomedical science and Quality
- Proven knowledge of ISO 13485
- Minimum of 2 years working experience in a Quality related field, preferably in the medical device industry.
- Advanced computer and Excel skills
- The ability to communicate effectively in English (written and spoken word)
**Responsibilities**:
Compliance
- Implements, manages, maintains, oversees, administrates, and improves ISO 13485 requirements and the quality management system.
- Initiate new SOPs as and when required, as per company needs.
- Ensure that all facets of the organisation comply with ISO 13485.
- Ensure that international and national legislation are applied and adhered to.
QMS
- Ensure that current processes are consistent with established QMS and legal standards.
- Ensure that new procedures or any procedure changes are updated to reflect current practice.
- Conduct and coordinate internal audits of all facets of the Company to ensure that all SOP and systems are adhered to.
- Managing change control through the Quality Management System and ensure that changes are documented and communicated accordingly to all relevant parties.
- Managing Risk Management document for the company.
- Working with all staff to establish quality requirements for external suppliers.
Non-conformances
- Ensure that all corrective actions are dealt with accordingly and that they are monitored for statistical purposes.
- Ensure that follow up of findings is performed and that corrective actions are sufficient.
Quality Control
- Ensure that Calibrations of all equipment are carried out timeously.
- Ensure that validation activities are carried as and when required.
- Obtaining results of process performance from management reports and make recommendations for improvement.
- Defining quality procedures in conjunction with operating staff.
Continuous Improvement
- Consider processes in terms of added value and continually improve processes based on objective measurements per department.
- Identify gaps between current and required practice, recommend and drive improvement activities to address the gaps.
- Assists to align all Departmental objectives to achieve those mentioned in the Company Policy.
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