Senior Quality Engineer

Agensi Pekerjaan Executive Recruiters Sdn Bhd; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Agensi Pekerjaan Executive Recruiters Sdn Bhd in Kuala Lumpur, Malaysia is seeking a Senior Quality Engineer to lead quality planning for new medical device projects. You will establish product-line QC plans and development of inspection standards for raw materials, in-process stages, and finished goods.

You will perform in-process and final product inspections, manage DHR, and ensure traceability. The role also requires GMP compliance in cleanroom environments and active participation in

Qualifications

• 5+ years in quality control within medical device manufacturing
• Experience with sterile or metallic implants
• Cleaning validation and cleanroom control
• ISO 13485 Internal Auditor certification
• Regulatory knowledge for sterile medical devices
• Experience with quality tools including the Seven QC Tools and Five Core Tools
• Proficient in risk management and product development workflows
• Strong cross-functional collaboration and communication in English and Mandarin

Responsibilities

• Lead quality planning for new projects and establish QC plans and inspection standards for materials, in-process, and finished goods
• Perform inspections, compile records, conduct compliance reviews, and ensure DHR accuracy and traceability
• Maintain inspection status control and disposition of non-conforming products
• Conduct GMP inspections in cleanrooms and drive adherence to GMP standards
• Lead cross-functional quality meetings to drive root-cause analysis and CAPA closures
• Run periodic statistical analysis of product line quality for improvements
• Participate in internal audits and assist with external audits by customers and regulators
• Train QC personnel on inspection standards and equipment operation
• Deliver company-wide training on inspection requirements and quality awareness
• Collaborate with cross-functional teams to achieve project objectives

Skills

Quality control

Quality management

GMP compliance

Root cause analysis

Cross-functional

Statistical analysis

Auditing

Training

English Mandarin

Education

Bachelor’s degree or above

ISO 13485 Internal Auditor

Tools

Minitab

Optical measuring instruments

Tensile testing machines

Job description

Senior Quality Engineer

Kuala Lumpur, Malaysia | Posted on 09/01/2026

• Industry Healthcare & Life Science - Medical Devices
• Work Experience 5+ years
• State/Province Perak
• Country Malaysia

Job Description

• Lead quality planning activities for new projects, establish product line quality control plans, and develop inspection standards for raw materials, in-process stages, and finished goods.
  
• Perform in-process and final product inspections; compile inspection and batch production records; conduct compliance reviews; and ensure Device History Records (DHR) are complete, accurate, traceable, and properly archived.
  
• Maintain proper product inspection status control and ensure timely and appropriate disposition of non-conforming or held products.
  
• Carry out routine GMP compliance inspections within cleanroom environments and drive adherence to GMP standards in cleanroom operations.
  
• Facilitate cross-functional quality meetings to conduct root cause analysis on issues such as non-conforming products, quality incidents, customer complaints, and adverse events; develop corrective action plans and monitor the closure of NCR and CAPA activities.
  
• Conduct periodic statistical analysis of product line quality performance and recommend continuous improvement initiatives.
  
• Participate in internal quality audits and assist in external audits conducted by customers and regulatory bodies.
  
• Train QC personnel on raw material, in-process, and finished product inspection standards, methodologies, and equipment operation to ensure independent and accurate execution of inspection activities.
  
• Deliver company-wide training on product inspection requirements, process compliance, and overall quality awareness.
  
• Undertake additional responsibilities assigned by the department head and collaborate effectively with cross-functional teams to ensure project objectives are achieved.
  

Requirements

• Bachelor’s degree or above in Chemistry, Biology, Pharmaceutical Sciences, Food Science, Electronics, Mechanical Engineering, or a related discipline, with a minimum of 5 years’ experience in quality control and quality management within medical device manufacturing, particularly involving sterile or metallic implants.
  
• Knowledgeable in cleaning validation, cleanroom control and on-site supervision, preparation of inspection documentation, and batch record review processes.
  
• Well-versed in quality management systems, with ISO 13485 Internal Auditor certification.
  
• Familiar with regulatory standards for sterile medical devices and experienced in operating inspection equipment such as optical measuring instruments and tensile testing machines.
  
• Proficient in new product development workflows and validation processes, with a strong understanding of risk management principles and practices.
  
• Experienced in utilizing quality methodologies and tools, including the Seven QC Tools, Five Core Quality Tools, and Minitab software, to support quality improvement initiatives.
  
• Detail-oriented, accountable, and analytical, with strong logical reasoning and structured problem-solving capabilities.
  
• Demonstrates strong cross-functional collaboration and cross-cultural communication skills, with fluency in English and Mandarin across listening, speaking, reading, and writing.