Donna Van Staden
Quality Assurance Manager
Cape Town,WC
Summary
Accomplished Quality Assurance Manager and Senior Scientist with over 13 years of work experience. Proven track record in managing quality assurance processes, developing innovative polymer nanofiber materials, and leading cross-functional teams to achieve organizational goals. Proficient in implementing quality control standards, conducting root cause analysis, and driving continuous improvement initiatives. Extensive experience with ISO 9001, ISO 13485, and ISO 22716 compliance. Holds a Master of Science in Polymer Science.
Overview
18
18
years of professional experience
2
2
Languages
Work History
Quality Assurance Manager and Senior Scientist
The Stellenbosch Nanofiber Company (Pty) Ltd
03.2017 - Current
- Lead the quality assurance department, overseeing a team of Quality Control Supervisors, Quality Engineer, Quality Inspectors, and Quality Assurance Assistants
- Managed the implementation and maintenance of the Quality Management System (QMS) compliant with ISO 9001:2015, ISO 13485:2016 and ISO 22716:2007
- Developed and brought a Class I Reusable Surgical Mask to market within 6 weeks during the COVID-19 pandemic, securing product licensing with SAHPRA
- Conducted full internal QMS audits and managed annual management review meetings
- Executed performance analysis and reviews related to quality objectives, and oversaw corrective and preventative actions
- Compiled and maintained product master files and managed organizational risk in line with ISO 14971
- Assisted with process and procedure development and supported all departments and teams.
Scientist
The Stellenbosch Nanofiber Company (Pty) Ltd
07.2011 - 02.2017
- Conducted standard R&D roles including literature searches, project planning, execution, laboratory experimentation, and product design and development
- Facilitated the transition of medical device products from R&D to production and led teams to meet order quantities
- Developed and implemented production systems and methods, job cards for record keeping, and production protocols
- Implemented quality control checks and procedures, trained scientists for production activities, and trained quality control inspectors
- Assisted in the implementation of the QMS and clean room design, and managed the ERP system setup and maintenance.
Research Assistant
Polymer Science Department, Stellenbosch University
01.2010 - 01.2011
- Focused on product development and quality improvement.
Private Tutor, Mentor, Demonstrator, Student Assistant
Polymer Science University Of Stellenbosch
01.2006 - 01.2009
- Tutored students in Physics and Chemistry
- Restructured and re-wrote Polymer Science course notes and practicals
- Mentored students during the Polymer Science Winter School Week
- Assisted students in First Year Mathematics (Bio) and Second Year (Engineering) Organic Chemistry
- Assisted in teaching First Year Chemistry
- Conducted research and development in Analytical Chemistry and Polymer Science.
Education
MSc: Polymer Science (Cum Laude) -
Stellenbosch University
01.2010
Honors BSc: Polymer Science -
Stellenbosch University
01.2007
BSc: Chemistry and Polymer Science -
Stellenbosch University
01.2006
Gr12: Matric Certificate (Pass endorsement with Distinction) -
Fairmont High School
01.2003
Skills
- Quality Assurance Management
- ISO Standards & Compliance
- Process Optimization
- Root Cause Analysis
- Team Leadership & Development
- Research & Development
- Regulatory Compliance
- Project Management
- Data Analysis
- Continuous Improvement
- Internal Audits
- Audit Coordination
Certification
- ISO 9001:2015 and ISO 13485:2016 (and MDR) Transition Training Course, Integrated Management Systems, June 2018
- Risk and Opportunities Workshop, Integrated Management Systems, June 2018
- Internal Auditing, Integrated Management Systems, April 2016
- ISO 13485, ISO 9001 & GMP, Integrated Management Systems, March 2016
- Laboratory Management Training Course, LabHouse (Pty) Ltd, September 2012
- Advanced Scanning Electron Microscopy and Microanalysis, Carl Zeiss Microscopy Academy, August 2012
- Various online short courses in ISO standards, risk management, and medical device regulations
Affiliations
- Member of the Golden Key International Honours Society
Languages
English
Afrikaans
Timeline
Quality Assurance Manager and Senior Scientist
The Stellenbosch Nanofiber Company (Pty) Ltd
03.2017 - Current
Scientist
The Stellenbosch Nanofiber Company (Pty) Ltd
07.2011 - 02.2017
Research Assistant
Polymer Science Department, Stellenbosch University
01.2010 - 01.2011
Private Tutor, Mentor, Demonstrator, Student Assistant
Polymer Science University Of Stellenbosch
01.2006 - 01.2009
MSc: Polymer Science (Cum Laude) -
Stellenbosch University
Honors BSc: Polymer Science -
Stellenbosch University
BSc: Chemistry and Polymer Science -
Stellenbosch University
Gr12: Matric Certificate (Pass endorsement with Distinction) -
Fairmont High School
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