Lexin Zhang
Hornsby,NSW
Summary
Highly detailed Quality Assurance Inspector recently exposed to the industry. Excited to learn more about the medical device industry in new environments and increase knowledge and understanding of medical device standards, regulations and the Quality Management System.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Quality Assurance Inspector
SpeeDx
03.2023 - Current
- Enhanced product quality by conducting thorough inspections on incoming components and finished products, and communicating quality issues with relevant teams.
- Conducted internal audits to verify adherence of quality management system to standards and regulations and identify opportunities for enhancement.
- Ensured compliance with industry standards through detailed review of QMS documentation.
- Providing new staff training for QMS and monitoring training plans.
- Attending project meetings and monitoring project timelines, providing input during product development life cycle.,
Partner
Uniqlo
05.2022 - 09.2023
- Greeted customers, helped locate merchandise and suggested suitable options.
- Consistently monitored sales floor and merchandise displays for presentable condition, taking corrective action such as restocking or reorganizing products.
- Offered each customer top-notch, personal service to boost sales and customer satisfaction. (Customer service award August 2022).
Sleep Coach
ResMed
12.2022 - 03.2023
- Quickly learnt new skills and adapted to a rapidly changing environment, taking up new responsibilities quickly in a demanding work setting.
- Proved successful working within tight deadlines and fast-paced atmosphere with an understaffed store. Communicated with NSW store and state managers in maintenance and efficient running of store operations in absence of staff and store managers.
- Knowledgeable with ResMed product range and core concepts surrounding sleep disorders and OSA.
Education
Bachelor of Engineering Honours - Biomedical Engineering
University of Sydney
Sydney, NSW04.2023
Bachelor of Science - Medical Science
University of Sydney
Sydney, NSW04.2023
Skills
- ISO13485
- MDSAP
- NC and CAPA
- SAP
- Quality Inspections
- Internal Audits
- Attention to detail
- Interpersonal communication
- Training and Mentorship
- Documentation Review
- Microsoft Word
- Adobe Sign
Certification
- Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness, BSI - September 2023
- ISO 13485 SeerPharma-REDI Training, SeerPharma - April 2023
- ISO 13485:2016 Lead Auditor Training, SAE International - April 2023
Timeline
Quality Assurance Inspector
SpeeDx
03.2023 - Current
Sleep Coach
ResMed
12.2022 - 03.2023
Partner
Uniqlo
05.2022 - 09.2023
Bachelor of Engineering Honours - Biomedical Engineering
University of Sydney
Bachelor of Science - Medical Science
University of Sydney
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