Senior Quality Engineer, Medical Devices - GMP & CAPA

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

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