Production Manager (Start-up - Medical Device)

Private Advertiser; Penang; On-site; MYR 180,000 - 280,000; Full time

Job summary

Private Advertiser is seeking a Production Manager to oversee daily manufacturing operations in a fast-paced environment. You will organize and deploy people, equipment, and materials to maximize efficiency while meeting quality and delivery targets.

Ideal candidates have a strong background in regulated medical device manufacturing, with a track record in Lean Six Sigma, process improvements, and team leadership.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Industrial Engineering, Biomedical Engineering, Life Sciences, or related discipline.
• Professional certification in Lean Six Sigma or Project Management is an added advantage.

Responsibilities

• Oversee daily production activities to meet manufacturing targets, quality standards, and delivery commitments.
• Organize and allocate production personnel, equipment, and materials to maximize efficiency and productivity.
• Monitor production schedules and adjust resources to meet changing business demands and customer requirements.
• Ensure products are manufactured in accordance with approved procedures, work instructions, regulatory requirements, and quality standards.
• Lead, coach, and develop production supervisors and operators to achieve operational excellence.
• Recruit, train, and retain a competent manufacturing workforce.

Skills

Leadership

People management

Regulatory understanding

Problem solving

Education

Bachelor's Degree in Engineering (or related)

Tools

ERP/MRP systems

Microsoft Office

Job description

Production Manager (Start-up - Medical Device)

Oversee daily production activities to ensure manufacturing targets, quality standards, and delivery commitments are achieved.

Organize and allocate production personnel, equipment, and materials to maximize operational efficiency and productivity.

Monitor production schedules and adjust resources to meet changing business demands and customer requirements.

Ensure products are manufactured in accordance with approved procedures, work instructions, regulatory requirements, and quality standards.

Resource & Capacity Management

Identify and implement the optimum utilization of manpower, equipment, floor space, and other operational resources.

Develop capacity plans and workforce strategies to support business growth and production demand.

Monitor equipment utilization and collaborate with Engineering and Maintenance teams to minimize downtime.

Lead, coach, and develop production supervisors and operators to achieve operational excellence.

Recruit, train, and retain a competent manufacturing workforce.

Establish performance objectives and conduct regular performance reviews.

Foster a culture of accountability, teamwork, continuous improvement, and employee engagement.

Ensure compliance with all workplace safety, health, and environmental requirements.

Quality & Regulatory Compliance

Ensure all manufacturing activities comply with ISO 13485, FDA 21 CFR Part 820 (or applicable Quality Management System requirements), GMP, and company procedures.

Drive quality initiatives to reduce defects, scrap, rework, and customer complaints.

Support internal and external audits and ensure timely closure of audit findings.

Promote a quality-focused culture throughout the production organization.

Collaborate with Engineering, Quality, and Operations teams to identify and implement process improvements.

Lead Lean Manufacturing, Six Sigma, Kaizen, and productivity improvement initiatives.

Develop innovative and cost-effective manufacturing solutions to improve quality, increase productivity, and reduce waste.

Establish and track key operational metrics such as OEE, yield, productivity, cycle time, and on-time delivery performance.

Problem Solving & Corrective Actions

Analyze production issues and implement effective corrective actions to eliminate recurring problems.

Lead investigations related to non-conforming products, manufacturing deviations, and process failures.

Manage customer complaints, Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and ensure effective implementation of preventive measures.

Drive root cause analysis using structured problem-solving methodologies.

Cross-Functional Collaboration

Work closely with Engineering, Quality Assurance, Supply Chain, Planning, Validation, and Maintenance teams to support production goals.

Participate in new product introductions (NPI), technology transfers, process validations, and capacity expansion projects.

Support business continuity and operational readiness initiatives.

Required experience:

Education

Bachelor's Degree in Engineering, Manufacturing, Industrial Engineering, Biomedical Engineering, Life Sciences, or related discipline.

Professional certification in Lean Six Sigma, or Project Management is an added advantage.

Experience

Minimum 8 years of experience in a fast-paced manufacturing environment, with at least 3 years in a managerial or leadership role.

Experience in medical device, healthcare, or other highly regulated industries is preferred.

Proven track record in people management, production planning, and operational improvement.

Knowledge & Skills

Strong understanding of medical device manufacturing processes and regulatory requirements.

Knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, GMP, and applicable regulatory standards.

Experience with Lean Manufacturing, Six Sigma, Kaizen, and Operational Excellence methodologies.

Strong analytical, problem-solving, and decision-making skills.

Excellent leadership, communication, and interpersonal skills.

Proficiency in ERP/MRP systems and Microsoft Office applications.

Ability to manage multiple priorities in a dynamic manufacturing environment.

Personal Attributes

Strong leadership and people development capability.

Results-oriented with a continuous improvement mindset.

High level of integrity, accountability, and professionalism.

Excellent organizational and stakeholder management skills.

Self-motivated and capable of working effectively in a fast-paced environment.