Sam Moses
Human Factors / Usability Engineering Lead
- Role
- Team Lead Manager at Biocon Biologics
- Location
- Thoothukudi, TN, IN
- LinkedIn followers
- 500 followers
About Sam Moses
A young, dynamic and qualified professional with wide experience in usability engineering/human factors, design controls, quality management systems, quality engineering, design quality assurance, management system certifications and regulatory affairs domain. Passionate about solving real world healthcare problems with innovative solutions which have a dramatic impact on healthcare delivery. A deep knowledge of Medical Devices/combination Product design controls throughout all stages of Design and Development including risk management, usability engineering and change control. I have been working in the quality domain for quite some time now, focusing on solutions addressing key quality problems in medical device sectors. Focused on achieving objectives/goals efficiently by using a wide range of quality & standard methods/techniques. Subject Matter Expert in the Key quality system processes such as NC-CAPA, Internal / External Audits, Change Control, Post Market Vigilance/Surveillance and Doc/Rec Control. Expertise with IEC 62366, ISO 13485, ISO 9001, ISO 14971, ISO IEC 62304, MDD, FDA 21 CFR 820.
Experience
Team Lead Manager
Oct 2024 — Present
Education
V.V. Clasic Matriculation School
High School
2003 — 2005
Anna University Chennai
Engineer's Degree
2005 — 2009
Skills
- 21 Cfr 820
- Iso
- Fda
- 21 Cfr Part 11
- Biotechnology
- Regulatory Affairs
- Lifesciences
- Quality Auditing
- Iso 13485
- Quality System
- Quality Systems
- V&V
- Haccp
- Regulatory Requirements
- Validation
- Quality Assurance
- Quality Management
- Change Control
- Capa
- Gmp
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