Job Description Summary
An exciting managerial opportunity for a Quality Manager - Africa. He/she will be responsible for a strategic oversight and leadership direction within the Quality Function.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
Want more jobs like this?
Get jobs in Midrand, South Africa delivered to your inbox every week.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us!
About the role
The Quality Manager - Africa is responsible for the quality management system maintenance and post market compliance with customer focused activities for Africa region under supervision of the Associate Director, Quality Assurance MEA and is member of the EMEA Quality Team.
Main responsibilities will include:
- Maintain the Quality Management System (QMS) and certification in accordance with ISO 13485:2016 and SAHPRA requirements.
- Ensure established processes in Africa sites are complying and in alignment with company Corporate and Regional Policies and Procedures.
- Ensure post market compliance (adverse events and field actions/recalls) and reporting to national competent authorities according to local regulations which apply to country activities, business needs and marketed products and services.
- Manage company Africa Suppliers, 3PL and Channel Partners (onboarding, performance evaluation, audits)
- Manage Internal, Corporate and External audits.
- Manage CAPA, quality plans and quality management review with LT (Leadership team)
- Fulfils the role of a Quality Management Representative for BD South Africa and other African Hub countries (excluding North Africa) in ensuring that executive management is informed of quality related matters impacting customers or identified potential risks so that appropriate actions are taken.
About you
- Scientific degree in a related field.
- Experience in quality or regulatory affairs roles in medical devices industry
- Knowledge/Experience with SAHPRA and other African Competent Authorities post market regulation and post market compliance reporting requirements (Adverse Events and Field Actions/Recall)
- Quality Management System knowledge and auditor certified ISO 13485 (mandatory)
- Reasoning ability: able to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to read, analyze and interpret technical, quality and regulatory documents.
- Ability to effectively present information and respond to questions from groups of managers, clients and customers.
- Computer skills (MS-Office)
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
To learn more about BD visit: https://bd.com/careers
Required Skills
Optional Skills
.
Primary Work Location
ZAF Sandton
Additional Locations
Work Shift