I am Murtuza Bohari, a dynamic Quality Assurance and Regulatory Affairs professional with over 13 years of experience in the Medical Device, Nutraceutical, Food and Dairy industries. I have a proven track record in developing, implementing, and managing quality systems, achieving ISO certifications, market access, and ensuring compliance with global regulations.
ABOUT ME
Professional Philosophy
I am dedicated to maintaining the highest standards of quality and compliance in all aspects of my work. Proactive approach, meticulous attention to detail, and ability to lead successful teams and projects have been the cornerstone of my career.
Professional Journey
- Supplier Quality Engineer at Zimmer Biomet ANZ
- Consultant at Klaston Management
- Senior Quality Associate at SQA Services Inc.
- Quality and Regulatory Manager at Canterbury Scientific Ltd
- Quality Assurance Manager at Xtend-Life Group Limited
- Quality Systems and Compliance Coordinator at Danone
- Laboratory Team Leader at Fonterra
- Microbiology Supervisor at AsureQuality
- Analyst/Senior Technician at AsureQuality
- Microbiology Technician at AsureQuality
EDUCATION
WORK HISTORY
Sep 2023 - Present
Supplier Quality Engineer
Zimmer Biomet ANZ
Sep 2023 - Sep 2023
Consultant
Klaston Management
Oct 2021 - Sep 2023
Senior Quality Associate
SQA Services, Inc.
Apr 2019 - Sep 2021
Quality and Regulatory Manager
Canterbury Scientific Ltd
Jun 2018 - Apr 2019
Quality Assurance Manager
Xtendlife Group Limited
Jan 2016 - Jun 2018
Quality Systems Coordinator
Danone
Apr 2015 - Dec 2015
Laboratory Team Leader
Fonterra
Nov 2013 - Apr 2015
Microbiology Supervisor
AsureQuality
Feb 2013 - Nov 2013
Analyst/Senior Technician
AsureQuality
Sep 2011 - Jan 2013
Microbiology Technician
AsureQuality
LICENSES & CERTIFICATIONS
Medical Devices – Quality Management Systems
Lead Auditor Training Course (ISO 13485:2016)
Requirements of the In Vitro Diagnostic Regulation
(IVDR) EU 2017/746
Implementation of the In Vitro Diagnostic Regulation
(IVDR) EU 2017/746
SKILLS
- Quality Management System (QMS)
- ISO 9001, ISO 13485, ISO 22000, ISO 22002, ISO 17025
- Leadership
- Project management
- People Management
- Risk Management
- ISO 14971
- Auditing
- ISO 19011
- ✔ Good Manufacturing Practice
- ✔ Medical Device Regulation (MDR)
- ✔ 3D Printing
- ✔ Medical Devices
- ✔ Auditing
- ✔ Validation
- ✔ Statistical Tools
- ✔ Statistical Process Control (SPC)
- ✔ Process Validation
- ✔ Regulatory Affairs
- ✔ Supplier Quality
- ✔ Product Quality
- ✔ Reporting
- ✔ Supplier Quality
- ✔ Risk Management
- ✔ Continous improvement
- Regulatory Affairs
- EU MDR, EU IVDR, 21 CFR Part 820
- Develop technical documentation files/Technical dossier
- Collaborate with regulatory agencies
- Supplier Quality
- Managing supplier qualification, auditing, change and performance.
- Process Validation
- Equipment qualifications
- Software validations
- Test method validations
CONTACTS
Let’s discuss how I can help your organisation improve patient lives and achieve its quality and regulatory goals to secure market access.
Get in touch!
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