Anju Tobin
Henderson,New Zealand
Summary
I am an experienced technical professional, passionate about providing quality service with expertise in Quality Assurance in Medical, Invitro Diagnostic, Semiconductor and Steel manufacturing industries. I can add value to the business with my organisational skills, methodical work practices and systems focused style of working and most importantly my ability to connect and relate within a team. I am a detail-oriented professional, skilled with multi-tasking, providing solutions as well as creating new and innovative ways of working.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Design Controls Engineer
Aroa Biosurgery
Auckland
04.2022 - 06.2024
- Managed design control documentation for product development, ensuring traceability and compliance with risk management standards.
- Led cross-functional teams to conduct hazard analysis and DFMEA for various design projects.
- Monitored compliance with IEC 62304 and IEC 60601-1 standards throughout software lifecycle.
- Maintained software development documentation in alignment with SDLC processes and regulatory requirements.
- Directed design transfer activities, facilitating smooth transition from development to manufacturing.
- Prepared and coordinated FDA 510(k) submission documents, resulting in successful approvals.
Quality and Regulatory Affairs Officer
Pictor Limited
Auckland
04.2018 - 04.2022
- Executed document control and maintained Quality Management System
- Conducted internal audits and coordinated the ISO 13485 certification audit, achieving successful external compliance.
- Directed nonconformance resolution through root cause analysis methods and established corrective and preventive measures.
- Evaluated suppliers for approved supplier list, enhancing supply chain reliability.
- Conducted quality control activities, reviewing batch manufacturing protocols and approving incoming goods.
- Developed CE marking technical documentation for in vitro diagnostic medical devices, following regulations.
- Registered new products into WAND database of Medsafe and obtained Free Sale certificate for medical devices.
- Prepared documents for Indian import license application, ensuring adherence to local regulations.
- Coordinated documentation for the clinical trial of the COVID diagnostic kit in NZ according to Ethics Committee standards.
Quality Management Assistant
Pyramid Engineering Silverdale
Auckland
10.2016 - 04.2018
- Managed non-conformances, change controls, CAPAs, and customer complaints to ensure compliance.
- Executed internal audits with quality team, minimizing reliance on external agencies.
- Produced comprehensive reports evaluating process effectiveness and identifying improvement opportunities.
- Developed strategies to address performance gaps, driving continuous enhancement.
Senior Verification and Validation Engineer
vTitan Corporation Pvt. Ltd.
03.2011 - 12.2015
- Verified that all systems function according to design parameters through testing and inspection.
- Scheduled validation testing with different departments and managers.
- Analyzed data to ensure compliance with FDA regulations.
- Maintained and calibrated testing equipment to consistently produce reliable results.
- Created detailed reports documenting results from validations activities.
- Established test protocols and methodologies to ensure compliance with industry standards.
- Implemented statistical quality control methodologies to enhance product quality.
Assistant Quality Assurance Engineer
TDK – EPC Corporation (PT. EPCOS Indonesia)
11.2008 - 10.2010
- Ensured outgoing component quality compliance with established specifications.
- Reported critical KPIs, including yield and customer claims, to senior management monthly.
- Controlled production quality while monitoring process yield.
- Prepared defect sample boards and conducted quality control for standardized production lines.
Lecturer
Amal Jyothi College of Engineering & Technology
01.2008 - 10.2008
- Company Overview: Industry: Educational Institution
- Industry: Educational Institution
Guest Lecturer
College of Engineering, Kidangoor
08.2007 - 01.2008
- Company Overview: Industry: Educational Institution
- Industry: Educational Institution
Education
Bachelor’s Degree -
Electrical & Electronics Engineering
Skills
- Internal auditing
- Documentation control
- Design control
- Verification and validation
- Technical writing
- Regulatory compliance
- Statistical analysis
- FDA regulations
- Product lifecycle management
- Clinical trials management
- ISO 9001 and ISO 13485 compliance
- ISO 14971 risk management
- IEC 62304 Software Lifecycle
- IEC 60601-1 safety standards
- Root cause analysis techniques: 8D, 5-Why, Ishikawa
- Data analysis tools: AnalyseIT, Minitab 15, MATLAB, LabVIEW
- Computer system validation
- Supplier evaluation
- FMEA methodology
- Six sigma principles
- Lean manufacturing
- CAPA management
Certification
- Bachelor’s Degree in Electrical & Electronics Engineering
- Certified internal auditor ISO 9001 Quality Management
- Certified tester ISTQB (International Software Testing Qualifications) foundation level
- Six Sigma Black Belt holder
- Attended 3-day workshop on Pharmaceutical Computer system validation (CSV)
- Attended training on Microsoft Project-Project Management
Personal Information
- Driving License: Class 1 Full license
- Visa Status: NZ Citizen
Timeline
Design Controls Engineer
Aroa Biosurgery
04.2022 - 06.2024
Quality and Regulatory Affairs Officer
Pictor Limited
04.2018 - 04.2022
Quality Management Assistant
Pyramid Engineering Silverdale
10.2016 - 04.2018
Senior Verification and Validation Engineer
vTitan Corporation Pvt. Ltd.
03.2011 - 12.2015
Assistant Quality Assurance Engineer
TDK – EPC Corporation (PT. EPCOS Indonesia)
11.2008 - 10.2010
Lecturer
Amal Jyothi College of Engineering & Technology
01.2008 - 10.2008
Guest Lecturer
College of Engineering, Kidangoor
08.2007 - 01.2008
Bachelor’s Degree -
Electrical & Electronics Engineering
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