Quality Assurance / Quality Control

Asia Medsource Group; Kuala Lumpur; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading medical device manufacturer in Kuala Lumpur is seeking an experienced Quality Assurance / Quality Control professional to oversee quality management functions, ensure compliance with local and international standards, and lead a quality control team. You will collaborate with various teams to maintain product quality, conduct audits, and manage customer feedback efficiently. The ideal candidate holds a Bachelor's degree and has at least five years of relevant experience in the disposable medical device industry.

Qualifications

• Minimum of five years of relevant experience in Operations/Process Improvement/Quality in disposable medical device manufacturing.
• Experience with ISO or equivalent quality management systems.
• Solid knowledge of FDA regulations, GMPs, ISO 13485, and related standards.
• Integrity, discipline, and adherence to principles.

Responsibilities

• Oversee quality management functions to ensure compliance with standards.
• Conduct audits for CSR and QMS to assess compliance.
• Collaborate with sourcing to ensure product developments meet quality standards.
• Manage customer feedback and implement corrective actions.

Skills

Proficiency in Mandarin

Solid English communication skills

Analytical skills

Attention to detail

Education

Bachelor's degree

Tools

MS Office Suite (Excel, Word)

Job description

JOB TITLE: Quality Assurance / Quality Control

We are seeking a dedicated and experienced QA/QC to join our team in Kuala Lumpur. In this role, you will be responsible for overseeing the quality management functions to ensure compliance with local and international standards, particularly within the medical devices and gloves manufacturing industries. Proficiency in Mandarin is preferred to facilitate clear communication and support our growing business operations.

Factory Audit

• Conduct Pre‑Corporate Social Responsibility (CSR) audits to assess ethical and social compliance within suppliers.
• Conduct Quality Management System (QMS) audits to ensure alignment with regulatory requirements and industry standards.
• Provide guidance and monitor suppliers’ implementation of corrective action plans based on audit findings.

Product Knowledge

• Collaborate with the sourcing team to ensure new product developments meet quality standards.
• Refine and develop product specifications in alignment with regulatory requirements and industry standards.
• Maintain and update product specifications as necessary to reflect changes in regulations or customer requirements.
• Ensure consistency and accuracy of product specifications across all relevant documentation.
• Collaborate with cross‑functional teams to incorporate feedback and ensure specifications meet quality standards.
• Implement quality improvement programs to enhance overall product quality and customer satisfaction.
• Participate in cross‑functional meetings to provide quality insights and recommendations for process improvements.
• Stay updated on industry trends, regulations, and best practices related to quality assurance and compliance.

Quality Control and Inspection

• Establish and maintain comprehensive product inspection plans to ensure consistency and quality improvement.
• Compile detailed inspection reports for analysis and record‑keeping purposes.
• Modify and improve product inspection plans as necessary to enhance quality control processes.
• Make informed product release decisions based on quality control results and strategic considerations.

Customer Feedback Management

• Review and analyze customer complaints to identify root causes and address issues effectively.
• Collaborate with suppliers and clients to implement corrective actions and resolve complaints promptly.
• Document complaint resolution processes and maintain records for future reference.

Team Management

• Provide leadership and guidance to quality control staff to ensure effective performance.
• Conduct regular training sessions on quality control procedures and standards for staff members.
• Assign tasks and responsibilities to team members according to their strengths and expertise.
• Monitor and evaluate staff performance, providing feedback and implementing performance improvement measures as needed.

Requirements & Qualifications

• Bachelor’s degree with a minimum of five years of relevant experience in Operations / Process Improvement / Quality in disposable medical device manufacturing.
• Experience managing or operating within an ISO or equivalent quality management system (QMS).
• Solid English communication skills, both verbal and written; good Mandarin communication is a plus.
• Solid knowledge of FDA regulations, GMPs, ISO 13485, Personal Protective Equipment (PPE) Regulation 2016/425, and other related ISO regulations/standards.
• Advanced analytical and complex problem‑solving skills, with experience in driving root‑cause analysis and corrective action initiatives.
• Experience with third‑party customer or regulatory audits.
• Integrity, discipline, and adherence to principles.
• Excellent communication, negotiation, and organizational skills at all levels.
• Strong project management and time management skills.
• Proactive attitude with attention to detail.
• Proficiency in MS Office Suite (Excel, Word).
• Willingness for frequent travel and possession of a valid driving license / own transport.