QA Technician
2 weeks ago
- To support HOD in ensuring the quality system requirements and system are established effectively, fully implemented and maintained in accordance with the relevant ISO QMS, GMP and/or QSR requirements.
- Responsible to ensure the activity of all quality inspections through in-process quality control, final quality control, in-coming quality control, investigation and corrective action on customer's complaint or non-conforming products.
- Provide guidance to the QC inspector in the aspects of quality control and assurance.
- Follow up with the Production personnel and other related personnel on quality issues.
- Provide Training for new or existing QA inspector and operators.
- To support in handling on the Calibration activities both internal and external.
- To coordinate with QA Engineers and relevant departments during validation activities to ensure timely execution and proper traceability.
- Assist in preparing validation sample records and reports in accordance with internal SOPs
- Reporting on the performance of quality system to superior as a basis of improvements.
- Monitor product quality by enforcing good control of processes and implementation of quality system in the manufacturing to ensure full compliance to specifications.
- Support superior the in handling of the Complaint activities and supplier control and qualification activities
- Any other responsibility that may be assigned by the superior from time to time within the agreed time frame.
Job Requirements/ Qualifications
- Educational Background: SPM/ STPM/ Diploma/ Degree in Engineering/ Applied science / Quality Management/ Equivalent
- Experience: Minimum of 3 years of working experience as QA Technician in product quality assurance within a manufacturing environment; experience in the medical device industry and working in cleanroom environment is highly advantageous.
- QC Inspection and testing skill (Dimension inspection and visual inspection), attention to details.
- Experience in Calibration and verification of equipment activities.
- Strong understanding of quality management systems (QMS) including ISO 13485 and ISO 9001.
- Preferably candidate with good knowledge of ISO 13485, GMP and FDA 21 CFR Part.
- Strong interpersonal, analytical and problem-solving skills.
- Team player, good leadership skill, Initiative, proactive, resourceful, able to multi-tasks and work independently.
- Good written and verbal communication skills in English and Bahasa Malaysia
- Proficiency in Microsoft Office (Excel, Word, PowerPoint) for data analysis and reporting.
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