QA ENGINEER

Job Summary:
Responsible for ensuring effective implementation and maintenance of the Quality Management System (QMS) in compliance with customer requirements, regulatory standards, and applicable legal requirements. Manage QA activities for plastic injection molding, secondary processes, and sub-assembly operations to ensure products meet quality specifications through effective process control, quality improvement, and compliance activities.

Job Responsibilities :

• Ensure quality system requirements are implemented, reviewed, and maintained in accordance with customer requirements, regulatory requirements, and applicable legal standards.
• Ensure effective and continuous Quality Assurance systems are maintained to ensure products delivered conform to customer specifications.
• Manage QA activities for assigned processes including plastic injection molding, lacquering, printing, laser etching, and sub-assembly operations.
• Lead and guide the IPQC team to ensure daily inspection activities are performed effectively and according to established procedures.
• Maintain and monitor SPC implementation to ensure process control and product quality consistency.
• Develop, review, and implement Engineering Change Orders (ECO), Part Inspection Plans (PIP), Part Management Plans (PMP), and Working Instructions (WI) for related processes.
• Ensure inspection methods, quality controls, and documentation are properly established to support smooth production operations.
• Review, verify, and approve QA reports, inspection records, and documentation prepared by QA Supervisors, Leaders, and Inspectors.
• Participate in customer complaint investigations and conduct root cause analysis to identify effective corrective actions.
• Support internal and external quality issue investigations together with Process Engineers and Customer Quality Engineers (CQE).
• Analyze QA rejection trends, follow up on improvement actions with process owners, and present quality performance updates to management.
• Review non-conforming products and determine appropriate disposition according to quality requirements.
• Monitor affected processes and coordinate with internal suppliers and internal customers to ensure quality issues are resolved effectively.
• Provide quality information and recommendations to Production, Engineering, Tool Room, and related departments for continuous improvement.
• Ensure inspection records, quality documents, and product traceability records are properly maintained and readily available.
• Support customer audits, internal audits, and quality system audits; prepare responses for audit findings and assist in audit closure activities.
• Ensure compliance with ISO 13485, ISO 9001, customer requirements, and company QEHS management system requirements.
• Recommend improvements to quality systems, procedures, and processes to enhance effectiveness.
• Train and develop QA team members to improve competency and ensure effective execution of quality activities.
• Escalate unresolved quality issues to the QA Manager / Assistant QA Manager for further action.
• Perform any other duties and responsibilities assigned by the Head of Department from time to time.

Job Requirements :

• Degree in Engineering, Quality Management, Manufacturing, or related field.
• 5 years above experience in Quality Assurance within plastic injection molding or medical device manufacturing industry is preferred.
• Knowledge of ISO 13485, ISO 9001, and Quality Management System requirements.
• Familiar with quality tools such as SPC, MSA, FMEA, 8D, CAPA, and root cause analysis. Experience in customer complaint handling, audit support, and non-conformance management.
• Knowledge of plastic injection molding processes and secondary processes is an added advantage.
• Good problem-solving, analytical, and communication skills.
• Able to work independently and collaborate effectively with cross-functional teams.

Pay: RM4,000.00 - RM7,000.00 per month

Benefits:

• Flexible schedule
• Free parking
• Health insurance
• Opportunities for promotion
• Professional development

Education:

• Bachelor's (Required)

Language:

• Bahasa Melayu, English, Mandarin (Preferred)

Work Location: In person