Quality Manager (Medical Cable Manufacturing | Penang) 质量经理（医疗电缆制造｜槟城）

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

Quality Manager (Medical Cable Manufacturing | Penang) 质量经理（医疗电缆制造｜槟城）

Quality Manager (Medical Cable Manufacturing | Penang) 质量经理（医疗电缆制造｜槟城）

📍 Work Location / 工作地点：
Penang Science Park North, Simpang Ampat, Malaysia 马来西亚槟城科学园北区 · 新邦安拔

💰 Salary Range / 薪资待遇
Attractive salary package commensurate with experience. 具竞争力的薪资待遇，具体根据经验面议。

📝 Job Summary / 职位概述
负责医疗电缆制造业务的整体质量管理，确保质量体系合规、制程稳定及产品长期可靠交付。
Responsible for leading overall quality management in a medical cable manufacturing environment, ensuring system compliance, stable processes, and long-term product reliability.

该岗位将作为质量体系与客户审厂的核心负责人，对接客户、第三方及内部跨部门团队。
This role acts as the key owner of the quality system and primary contact for customer and third-party audits, working closely with cross-functional teams.

📋 Key Responsibilities / 岗位职责

负责建立、维护并持续优化符合 ISO 13485 与 ISO 9001 的质量管理体系。
Establish, maintain, and continuously improve the Quality Management System in compliance with ISO 13485 and ISO 9001.

作为主要负责人应对客户审厂、第三方审核及法规相关检查。
Serve as the primary representative for customer audits, third-party audits, and regulatory inspections.

全面管控医疗电缆生产全过程质量，包括挤出、组装、屏蔽、测试及终检。
Manage end-to-end process quality across extrusion, assembly, shielding, testing, and final inspection.

主导不合格品处理、CAPA、根因分析及改善成效的跟进与验证。
Lead non-conformance handling, CAPA implementation, root cause analysis, and effectiveness verification.

与工程及生产团队协作，推进制程验证（IQ/OQ/PQ）及工艺变更管理。
Collaborate with Engineering and Production teams on process validation (IQ/OQ/PQ) and change management.

确保产品在生物相容性、灭菌方式适配及可靠性测试方面符合医疗标准要求。
Ensure compliance with medical requirements related to biocompatibility, sterilization compatibility, and reliability testing.

管理并培养 QA/QC 团队，提升整体质量意识与执行能力。
Manage and develop the QA/QC team to enhance overall quality capability and awareness.

审核并批准质量文件、SOP、检验规范及风险评估文件。
Review and approve quality documentation, SOPs, inspection standards, and risk assessment documents.

🎓 Requirements / 任职要求

工程、质量或相关专业本科及以上学历。
Bachelor’s degree or above in Engineering, Quality, or related disciplines.

具备 8 年以上医疗器械或医疗零部件制造行业质量管理经验。
Minimum 8 years of quality management experience in medical device or medical components manufacturing.

熟悉 ISO 13485 质量体系运作，并具备实际客户审厂经验。
Strong hands‑on experience with ISO 13485 and customer audits.

对制程质量、制造控制及验证流程有扎实理解与实操经验。
Solid understanding and hands‑on experience in process quality, manufacturing control, and validation.

具备医疗电缆、导管、连接器或精密医疗零部件经验者优先。
Experience in medical cables, catheter, interconnects, or precision medical components is highly preferred.

具备良好的团队管理、跨部门沟通及问题解决能力。
Strong leadership, cross‑functional communication, and problem‑solving skills.

📞 Contact Information / 联系方式
Email：***@globalhirecareer.com