Responsibilities:
The National Quality Officer has the responsibility to ensure compliance to international standards within the assigned national business units, which includes designing and implementing Quality Management Systems, conducting audits, advising on corrective actions, and assessing general risks of the national business units.
This role will require traveling and on-site visits at the various locations around South Africa (including Durban and Cape Town)
Compliance to ISO 9001 Standard
- Designs, implements, and maintains Quality Management Systems documentation and rollout of the quality management practices in compliance with documented company policies and procedures.
- Implements and monitors Quality Management System (QMS) through a central reporting database.
- Guarantees compliance to QMS through conducting regular internal reviews/audits.
- Timeously addresses corrective actions raised, gives feedback and facilitates the implementation of controls or practices to prevent reoccurrence.
- Conducts periodical Internal QMS Audits.
- Facilitates the external audit on the ISO 9001 system and addresses timeously any major and/or minor non-conformances raised (acts as the responsible person during external/certification Audits).
- Provides a periodical risk assessment report on the effectiveness of the QMS and improvement plan.
Compliance to ISO 13485 Standard
- Establishes the requirements for compliance with ISO 13485 in accordance with applicable frameworks.
- Ensures compliance with the requirements of ISO 13485.
- Creates and maintains Medical Device Files.
- Conducts risk assessment in accordance to ISO 14971.
- Performs regular internal audits to ensure compliance with specific ISO 13485 requirements.
Responsibilities as Health and Safety Officer
- Ensures compliance with applicable Health and Safety Requirements for all sites, business units.
- Prepares all necessary documentation and provides necessary guidance in terms of all health and safety requirements for projects and other site installations, including but not limited to site risk assessments, representative appointments, assignment of responsibility etc.
Responsibilities as Environmental Officer
- Implements, maintains, and monitors an environmental management system based on the operations’ approved Environmental Management Program
- Updates and maintains the operations’ environmental aspect register and monitoring management programs/actions for significant aspect.
Additional Competencies:
- Strong sense of self to enforce governmental laws, rules, and regulations, and initiates enforcement actions in a way that the stakeholders perceive as fair, objective, and reasonable.
- Ability to formally delivers information to groups, conveys ideas and facts orally using language the audience will best understand.
- Must be able to communicate using concise, clear, appropriate language; Structure’s ideas clearly and logically; follows procedures.
- Able to Diligently attends to details and pursues quality in accomplishing tasks.
- Trustworthy to earns others’ trust and respect through consistent honesty and professionalism in all interactions.
- Adapt into a culturally diverse work environment.
Education & Skills:
- Bachelor’s Degree or similar qualification in life science, Operational Management, Quality Management
- Minimum of 3-5 years’ experience in quality assurance and servicing; preferably experience within the medical equipment industry, or similar and applicable environment.
- Experience in internal and external (certification) audits for ISO [Phone Number Removed]; or SHEQ Audit.
- Sound computer and MS Office skills
Desired Skills:
- specialized health services
- Research And Development
- Pharmaceuticals
- Biopharmaceuticals
- Medical Devices
- Disposables
- Health Supplements
Desired Work Experience:
- 2 to 5 years Quality Control
Desired Qualification Level:
- Degree
About The Employer:
Supra Healthcare, a division of Avacare Health Group, an integrated healthcare group serving the African region through the distribution and supply of pharmaceuticals, medical consumables, consumer health and medical equipment.
The birth of our Group took place in 1996 with a vision to make a difference to the people of Africa. Our innate passion and commitment to deliver timeously has helped us make our mark in the pharmaceutical and healthcare arena.