Samantha Khor Hui Shi
Product Engineer
Summary
A product engineer with 6 years experience in personal care industry, mainly focused on continuous product and quality improvement. Experienced Quality and Compliance professional with a background in engineering and regulatory affairs seeking to contribute to the smooth operations and compliance of B.Braun Medical Industries Sdn. Bhd. Committed to ensuring regulatory adherence, managing CAPAs, and driving continuous improvement in quality systems.
Overview
6
6
years of professional experience
3
3
Languages
Work History
Product Engineer
Nibong Tebal Personal Care Sdn. Bhd.
07.2018 - Current
- Develop innovative plans and solutions in carrying out technical programs.
- Study product performance in the market to understand the latest trend.
- Identify critical parameters for greater process control.
- Analyzing data and preparing reports.
- Troubleshooting and resolving technical issues.
- Collaborating with cross-functional teams on engineering projects such as test run new products/materials and quality improvement projects.
- Participating in the development of manufacturing procedures such as SOP, control plan, specification and working instruction that compliance with GMP and ISO regulatory requirements.
- Assist QMS Lead Auditor in pre-audit preparation such as prepare audit plan/schedule.
- Trained internal auditor to conduct internal audit for both ISO9001 and GMP process.
- Audit reporting and follow up corrective actions required after internal audits and ensure timely response and implementation.
- Coordinate and conduct root cause analysis for non-conformance activity and ensure timely implementation and closure for all CAPAs.
- Coordinate and conduct root cause analysis for customer complaints with related team and ensure timely closure for customer complaints.
- Drive continuous improvement in quality and compliance projects.
- Staying current on laws and regulations to ensure compliance.
Education
Bachelor of Chemical Engineering - Chemical Engineering
University Malaysia Pahang
Pahang,Malaysia 04.2001 -
Skills
Quality Management System (ISO9001, GMP)
Audit Coordination: Internal audit planning and execution
CAPA Management: Corrective Action and Preventive Action processes
Root Cause Analysis: Problem-solving and analytical skills
Statistical Analysis: SPC, Power BI
Project Management: Coordination and follow up on quality improvement project
Communication: Strong written and verbal communication skills
Timeline
Product Engineer
Nibong Tebal Personal Care Sdn. Bhd.
07.2018 - Current
Bachelor of Chemical Engineering - Chemical Engineering
University Malaysia Pahang
04.2001 -