Daisy Zhang
Surrey,BC
Summary
Dynamic QA/RA Manager with a proven track record at Artron Bioresearch Inc., specializing in regulatory compliance and fostering cross-functional collaboration. Expert in streamlining product registration and enhancing quality management systems, significantly improving workflow efficiency. Skilled in leading teams through complex audits, ensuring ISO 13485 and MDSAP adherence.
Overview
9
9
years of professional experience
Work History
QA/RA Manager
Artron Bioresearch Inc.
Burnaby, British Columbia
07.2016 - Current
- Managed product registrations, including reviewing product technical documents, and design changes requiring regulatory approval before implementation.
- Responsible for product classification, preparation of regulatory submissions for device applications from Health Canada.
- Responsible for the assessment of post-market surveillance and labeling review.
- Planned and delivered training sessions on regulatory requirements to the R&D, QA/QC, and Marketing teams to improve employee effectiveness and address areas of weakness.
- Responsible for the coordination of product recalls and support during audits and inspections.
- Lead management review meeting, pre-submission meetings with regulators, submit meeting minutes, and engage necessary cross-functional teams in the meeting.
- Managed external audits and internal audits, and ensured compliance with ISO 13485 and MDSAP.
- Oversaw daily operations, maintaining efficiency and the Quality Management System.
- Established processes to ensure efficient workflow throughout the organization.
Education
Master of Science - Physiological Engineering, Biotechnology
University of Poitiers
Poitiers, France11-2012
Skills
- Regulatory compliance
- Product registration
- Post-market surveillance
- Quality management
- Training delivery
- Internal auditing
- Cross-functional collaboration
- Document review
- Process improvement
Languages
English
Professional
Timeline
QA/RA Manager
Artron Bioresearch Inc.
07.2016 - Current
Master of Science - Physiological Engineering, Biotechnology
University of Poitiers
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