Noelle Kow
Kuala Lumpur
Summary
Dedicated and detail oriented Quality Specialist with 6 years working experience in regulated Medical Device company, physically fit and adaptable to work in manufacturing and Business Shared Service Center environment. Capable to act as both collaborative team member and individual contributor.
Overview
7
7
years of professional experience
3
3
years of post-secondary education
3
3
Certifications
3
3
Languages
Work History
Quality Specialist
Edwards Lifesciences
1 2023 - Current
- Performed data mining and analyzed quality and performance data to support operational decision-making
- Provided regular key quality metrics updates to APAC leadership team by communicating consistency problems or adverse trending
- Served as SME for document change control management to ensure impact assessed and periodic review completed in timely manner
- Monitored supplier performance by maintaining quality certification, conducted supplier review board and as supplier audit coordinator
- Conducted detailed root cause analyses following any non-conformance events, leading to swift identification and mitigation of potential risks
- Participated in Quality Audits covering ISO 9001, ISO 13485 and Medical Device Single Audit Program (MDSAP)
Chemist Cum Quality Executive
Supervision Optimax Sdn Bhd
01.2017 - 12.2022
- Coordinated with cross-functional departments such as engineering and marketing to ensure smooth transition of products from R&D stage to commercialization
- Maintained quality plan, quality objectives and quality procedures at all levels to ensure products conform to Good Manufacturing Practice (GMP) and regulatory requirements
- Supported in non-conforming (NCR) report and implementation of corrective and preventive actions (CAPA) closed effectively in timely manner
- Oversaw document change control system to ensure all files and records are well maintained in Good Documentation Practice (GDP)
- Participated in Quality Audits covering ISO 9001, ISO 13485 and Medical Device Single Audit Program (MDSAP)
Education
Bachelor of Science - Chemistry
University Tunku Abdul Rahman (UTAR)
Kampar, Perak 10.2013 - 05.2016
Skills
Quality Metrics Reporting
Quality Management System
Documentation Control
Quality Auditing
Quality Assurance
Microsoft Office
Analytical Tool (Power BI)
Certification
08/01/2019, ISO 9001:2015 & ISO 13485:2016 Internal Auditor Training
Timeline
Chemist Cum Quality Executive
Supervision Optimax Sdn Bhd
01.2017 - 12.2022
Bachelor of Science - Chemistry
University Tunku Abdul Rahman (UTAR)
10.2013 - 05.2016
Quality Specialist
Edwards Lifesciences
1 2023 - Current
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