Consultant
ISO 13485 & ISO 9001 Lead Auditor at
Blended Business Solutions
Centurion, Gauteng
Language: English | Standard: ISO 9001, ISO 13485
I am a seasoned implementation specialist with a proven track record of successfully guiding companies through ISO 13485:2016 and ISO 9001:2015 certification journeys. My expertise extends beyond implementation, as I am also a certified Lead Auditor for ISO 13485:2016 and an Internal Auditor for ISO 9001:2015, registered with the South African Auditor and Training Certification (SAATCA) as a Provisional Auditor for ISO 13485. I have led numerous companies through successful certification processes and continue to oversee both standard implementation and ongoing surveillance audits.
CAREER HISTORY
Company: Blended Business Solutions
Position: ISO 13485 & 9001 Lead Auditor
Years: Sept 2021 - Current
Responsibilities:
QMS Development: Development of quality management systems which meet the requirements of ISO standards.
Planning Audits: Develop audit plans based on the requirements of the ISO standard(s) applicable to the organization.
Conducting Audits: Lead and conduct audits of the organization's management system.
Communication: Effectively communicate with auditees to explain the purpose and scope of the audit and document and report audit findings, including non-conformities and areas for improvement.
Reporting: Prepare comprehensive audit reports detailing findings, observations, and recommendations and present audit reports to management and relevant stakeholders.
Company: Bicacon Group
Position: Quality Manager
Date: September 2015 - Current
Responsibilities
Implement ISO standards: ISO 9001:2015, ISO 45001:2018, ISO 13485:2016, ISO 17025:2017, and ISO 14001:2015
Collaborate with Business Units Leadership team and Department Heads for shared responsibility in compliance and quality assurance
Participate in Quality Management Review process
Lead quality systems process mapping, monitoring, and improvement
Manage and host external compliance audits related to Business Unit quality standards
Perform and host internal audits as per schedule, ensuring timely closure of audit actions
Provide quality expertise for issue resolution,
Establish processes for continuous improvement,
Ensure regulatory compliance with Health and safety, and environmental management regulations.
Education
Certificates
