Operations Manager

Location : Johor Bahru, Malaysia

Industry : Medical Devices Manufacturing

Reporting to :  Production Director

Job Summary

We are looking for an experienced and hands-on Operation Manager to lead the setup and full-scale operations of a new medical device manufacturing facility in Johor Bahru. The ideal candidate should have strong experience in greenfield projects, manufacturing operations, regulatory compliance, and team leadership within the medical devices or other regulated industries.

Key Responsibilities

Lead the full setup of a new manufacturing facility from site preparation, layout planning, equipment installation, to pilot production.

Manage day-to-day plant operations, including production, quality, maintenance, planning, and logistics.

Ensure full compliance with medical device regulatory standards (ISO 13485, FDA, MDA, etc.).

Drive continuous improvement initiatives for productivity, efficiency, and cost control.

Establish SOPs and ensure a safe, efficient, and clean manufacturing environment.

Build, lead, and train cross-functional teams to support ramp-up and future growth.

Coordinate with HQ and external stakeholders (e.g., vendors, government agencies, consultants).

Oversee operational KPIs and ensure achievement of performance targets.

Requirements

Bachelors Degree in Engineering, Manufacturing, or related fields.

Minimum 5 years of experience in operations or plant management, ideally in medical devices or other regulated industries (e.g., pharmaceuticals, electronics).

Proven experience in greenfield project or new plant setup is a must .

Familiar with ISO 13485, GMP, and other relevant compliance requirements.

Excellent leadership, communication, and organizational skills.

Strong problem-solving skills and ability to work under pressure.

Proficient in English and Bahasa Malaysia; Mandarin is a plus.

Must be based in or willing to relocate to Johor Bahru.