Your purpose:
- Implement and maintain an ISO 13485 quality management system for class 3 medical devices.
- Assist with Research and Development of medical devices
You will:
- Implementing and maintaining an ISO 13485 quality management system
- Ensure that the components and materials provided by suppliers meet all relevant regulatory standards.
- Create and maintain all required documentation outlined in the relevant standards.
- Work with biomedical engineers to develop and test device validation criteria.
Essential skills requirements:
- Bachelor’s degree in a scientific or engineering field is required (a Master’s degree is preferred).
- You MUST have Medical devices or related industries experience including pharmacology.
- Able to function in a highly innovative and agile environment.
- Lead or part of a team that has successfully implemented an ISO 13485 quality management system for a class 2/3 medical device.
- High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.
- Strong written and verbal communication skills are required, including proficiency with standard office productivity suite and data analysis software.
- Successful communication skills, business acumen and assertive decision-making ability.
Desired Skills:
- medical devices
- biomedical
- opthalamology
- ISO13485
- quality assurance
- quality technology
- research and development medical devices
- medical device engineering
Desired Work Experience:
- 5 to 10 years Quality Control
Desired Qualification Level:
- Masters
About The Employer:
Medical technology company pioneering a new class of ocular implants designed to treat glaucoma, the leading cause of irreversible blindness worldwide. The company has received multiple scientific grants and awards both locally and internationally. Currently undergoing a period of growth and team expansion following a significant investment from the Technology and Innovation Agency of South Africa.
Salary parameters are guides only in order to identify the Best candidates for the role.