AAINAA SHAHIRAH ZULKARNAIN
NIBONG TEBAL,Malaysia
Summary
Experienced Quality Engineer with keen eye for process improvement and problem-solving. Consistently implemented quality control measures that enhanced product reliability, reducing defects and boosting customer satisfaction. Skilled in cross-functional team leadership, driving projects to completion with focus on operational excellence.
Overview
1
1
Language
1
1
Certification
5
5
years of post-secondary education
4
4
years of professional experience
Work history
Quality Engineer 1
Teleflex Medical Sdn Bhd
2024.07 - Current
- Improved product quality and operational efficiency by collaborating with Process Engineers and production teams, monitoring DPM trends, and implementing corrective actions that reduced defects by 50%.
- Maintained high product quality standards by working closely with production and manufacturing teams to support non-conformance (NC) investigations, audits, and quality improvement initiatives, contributing to reduced customer complaints.
- Investigated customer complaints through cross-functional collaboration with production and process engineering teams, performing root cause analysis and supporting CAPA implementation.
- Supported New Product Introduction (NPI) by collaborating with R&D to implement Quality Assurance Specifications (QAS) and establish Visual Standards (VSTD) to ensure consistent product acceptance criteria across QA and Production.
- Contributed to quality improvement and validation activities, including Installation Qualification (IQ) and Project Validation Plans (PVP), ensuring compliance with medical device quality requirements.
- Identified supplier-related quality issues during incoming inspections and escalated defects to Supply Quality Engineer (SQE) for corrective actions, enhancing supplier quality.
- Support Continuous Improvement Projects (CIP) to improve QA operational efficiency and reduce process costs while assisting in internal and external quality audits.
- Trained and mentored new QA auditors and developed Job Instruction Breakdown (JIB) documentation for Process Test Methods (PTM) to ensure consistent QA inspection practices.
- Coordinated with teams to implement process and procedural changes, preventing recurrence of quality issues.
Supply Quality Engineer
Nationgate Holdings Berhad
2022.12 - 2023.01
- Evaluated newly received supplier parts with inspectors to ensure compliance with engineering and manufacturing specifications.
- Guided inspectors in measuring critical dimensions and verified that supplier-provided dimensions matched technical drawings.
- Confirmed that all critical dimensions in engineering drawings could be accurately inspected.
- Maintained and updated Inspection Standards (IS) for incoming materials to ensure quality compliance.
- Monitored incoming materials for defect and resolved part quality issues in coordination with cross-functional teams.
- Communicated with suppliers regarding nonconforming parts, provided feedback, and coordinated parts returns.
- Oversaw the movement of parts in and out of the MRB (Material Review Board) area and updated records in the ERP system.
Education
Bachelor of Mineral Resources Engineering - Hons
Universiti Sains Malaysia
Nibong Tebal, Penang 2018.09 - 2022.10
Matriculation - Physical Science
Perak Matriculation College
2017.01 - 2018.01
Skills
- Quality assurance methods
- Continuous improvement initiatives
- Root cause analysis expertise
- Quality assurance advocacy
- Root cause analysis
- Root cause analysis
Languages
Languages: Bahasa Malaysia (Fluent), English (Fluent)
Certification
JIB Trainer
ADDITIONAL EXPERIENCE
Internal Industrial Training in Universiti Sains Malaysia (2021)
- Exposed to the laws and regulations in mining, including the role of government bodies which are JMG, DOE, and DOSH.
- Exposed to the Environmental Impact Assessment (EIA) for mining activity, consists of EIA requirements and its legislation, scoping exercise and impact assessment.
- Assigned to create a simple 3D model string, and the Operational Mining Scheme (OMS) includes designing a mine pit using GEOVIA Surpac for the desired project.
- Develop a financial model based on real data provided by industry.
- Introduced to the estimation techniques and grade control strategies and procedures used in mine planning.
- Designed a tailing pond system compatible with wastewater generation for the project site.
- Participated in the project's weekly activities, which included moderating the sessions' sharing session with alumni via webinar.
Timeline
Quality Engineer 1
Teleflex Medical Sdn Bhd
2024.07 - Current
Supply Quality Engineer
Nationgate Holdings Berhad
2022.12 - 2023.01
Bachelor of Mineral Resources Engineering - Hons
Universiti Sains Malaysia
2018.09 - 2022.10
Matriculation - Physical Science
Perak Matriculation College
2017.01 - 2018.01