Vivian Low
Senior QA & Technical Manager
Cyberjaya, Selangor
Summary
Accomplished Senior Quality Manager with over 10 years of experience in the healthcare industry, specializing in quality control, regulatory compliance, and process optimization within operational environments. Proven track record of implementing quality management systems (QMS), leading cross-functional teams, and driving continuous improvements to ensure product quality, safety, and regulatory adherence. Recognized for strong problem-solving abilities, effective communication with stakeholders, and a commitment to upholding the highest standards in healthcare product quality and compliance.
Dedicated to continuous improvement and ensuring high-quality standards that align with both regulatory requirements and organizational goals.
Overview
12
12
years of professional experience
3
3
Languages
Work History
Senior QA & Technical Manager
SHIELD Scientific Sdn Bhd
08.2014 - Current
- Lead and manage the Quality and Regulatory Affairs teams, overseeing compliance with ISO, FDA, and EU MDR standards.
- Oversee quality control and assurance processes, including quality audits, supplier evaluations, and regulatory compliance assessments, ensuring alignment with healthcare industry standards and regulations.
- Created comprehensive documentation of processes and procedures to ensure consistency throughout the department''s operations.
- Provide technical guidance and responses to customer inquiries, including written and verbal explanations on sterilization and production processes for products.
- Led training sessions for staff on quality protocols, regulatory updates, and best practices to foster a culture of continuous improvement.
- Serve as the primary contact for customer quality-related inquiries and complaints, developing effective response strategies to address issues and improve satisfaction.
- Develop and execute internal audits, risk assessments, and CAPA (Corrective and Preventive Actions) to proactively address quality issues and maintain regulatory compliance.
- Led cross-functional teams for successful product launches, ensuring timely delivery and high-quality results.
- Built trusted relationships with stakeholders through clear communication and collaborative problem-solving efforts.
- Communicated project status, delivering audience messages, and change management with clients.
QA Manager
Mayer Manufacturing Sdn Bhd
07.2012 - 03.2014
- Overview control of the quality assurance functions with responsibility for maintenance of site accreditation (ISO 22000:2005, GMP, HACCP & BRC/IOP), training and site hygiene.
- Managed cross-functional teams to ensure seamless coordination between QA, development, and support departments.
- Investigated customer complaints and performed corrective actions to resolve quality issues.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
- Conducted root cause analysis on recurring defects, implementing corrective measures to prevent future occurrences.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
Education
Bachelor of Engineering Technology - Biological & Agricultural
University Putra Malaysia
Serdang, Selangor 04.2001 -
Skills
- Quality Management Systems (QMS): ISO 9001, ISO 13485
- Compliance and Regulatory Standards: GMP, MDR, PPER
- Auditing and Inspection: Internal Audits, Supplier Audits, CAPA Management
- Data Analysis: Root Cause Analysis, Failure Mode and Effects Analysis (FMEA), Risk Assessment
- Multitasking Abilities
- Technical understanding
- Communication skill
- Presentation skill
Accomplishments
- Recognized by management for exceptional dedication to product quality and compliance standards, contributing to the facility’s top performance during certification & customer audits.
- Developed training programs to strengthen quality culture within organization.
- Enhanced regulatory compliance and readiness by leading organization through a series of internal process reviews and update to align with ISO 13485 and related regulatory requirements.
Timeline
Senior QA & Technical Manager
SHIELD Scientific Sdn Bhd
08.2014 - Current
QA Manager
Mayer Manufacturing Sdn Bhd
07.2012 - 03.2014
Bachelor of Engineering Technology - Biological & Agricultural
University Putra Malaysia
04.2001 -
Similar Profiles
Putri Noorliana Megat NawahirPutri Noorliana Megat Nawahir
Manufacturing Specialist II at Boston Scientific Medical Device Malaysia Sdn BhdManufacturing Specialist II at Boston Scientific Medical Device Malaysia Sdn Bhd
Baradt GanesanBaradt Ganesan
Business System Analyst III at Boston Scientific Medical Device (Malaysia) Sdn. BhdBusiness System Analyst III at Boston Scientific Medical Device (Malaysia) Sdn. Bhd
Ain Nashwa Md AszmanAin Nashwa Md Aszman
Regulatory Compliance Officer at SPD SCIENTIFIC (M) SDN BHDRegulatory Compliance Officer at SPD SCIENTIFIC (M) SDN BHD