Senior Quality Manager, Medical Devices — ISO13485 (Penang)

Global Hire Career; Seberang Perai; On-site; MYR 150,000 - 200,000; Full time

Job summary

A medical manufacturing company in Penang seeks a Quality Manager to lead the quality management system in compliance with ISO 13485. Responsibilities include managing end-to-end quality processes, leading audits, and enhancing the QA/QC team's skills. The ideal candidate has at least 8 years of experience in medical devices, strong leadership skills, and a solid understanding of manufacturing controls. Competitive salary commensurate with experience is provided.

Benefits

Attractive salary package

Qualifications

• Minimum 8 years of quality management experience in medical device manufacturing.
• Strong hands-on experience with ISO 13485 and customer audits.
• Solid understanding in process quality and manufacturing control.

Responsibilities

• Lead overall quality management for medical cable manufacturing.
• Serve as primary representative for customer audits and regulatory inspections.
• Manage end-to-end quality across various production processes.

Skills

ISO 13485 experience

Quality management

Leadership skills

Problem-solving skills

Education

Bachelor’s degree in Engineering or related fields

Job description

A medical manufacturing company in Penang seeks a Quality Manager to lead the quality management system in compliance with ISO 13485. Responsibilities include managing end-to-end quality processes, leading audits, and enhancing the QA/QC team's skills. The ideal candidate has at least 8 years of experience in medical devices, strong leadership skills, and a solid understanding of manufacturing controls. Competitive salary commensurate with experience is provided.