Manufacturing Plant Manager (Medical Devices)

Link Compliance; Pekan Nanas; On-site; MYR 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manufacturing Plant Manager for their medical devices division. This pivotal role involves overseeing daily operations, managing production schedules, and ensuring compliance with industry standards. The ideal candidate will lead initiatives to enhance product quality and operational efficiency while fostering a culture of continuous improvement. If you are a results-oriented leader with a passion for excellence in manufacturing, this opportunity offers a chance to make a significant impact in a dynamic environment.

Qualifications

• 5+ years of hands-on manufacturing or operations management experience.
• Strong focus on product quality and manufacturing processes.
• Proficient in report writing and presentations.

Responsibilities

• Implement and monitor manufacturing KPIs for quality and delivery.
• Lead lean manufacturing initiatives to reduce costs and waste.
• Ensure compliance with ISO 13485 and other medical device standards.

Skills

Lean Manufacturing

Six Sigma

Time Management

Problem-Solving

Interpersonal Skills

Organizational Skills

Education

University Degree in Engineering

Lean and/or Six Sigma Certification

ERP Training and Certification

Tools

ERP Systems

MRP Systems

Job description

Manufacturing Plant Manager (Medical Devices)

Job Description:

Job Title: Manufacturing Plant Manager

Reports to: VP Operations

The Plant Manager reports directly to the VP of Operations and is expected to be a hands-on, results-oriented leader responsible for managing the daily activities of the manufacturing plant, including operations and production. The role emphasizes product quality, cost management, continuous improvement, and prioritizing customer service.

Job Responsibilities:

1. Implement, monitor, and achieve manufacturing KPIs such as on-time delivery, supplier performance, and product quality.
2. Develop and implement processes aligned with strategic initiatives; prepare and present annual budgets.
3. Manage daily priorities to ensure production schedules meet inventory, cost, and quality goals.
4. Analyze production and quality metrics to proactively implement improvements.
5. Ensure compliance with ISO 13485, other medical device standards, and applicable legislation including WSIB, WHMIS, and Workplace EH&S.
6. Oversee business-wide JHSC activities, including fire and evacuation plans, first aid, and workplace audits.
7. Organize and oversee daily operations to ensure resource availability and stakeholder satisfaction.
8. Promote a culture of continuous improvement, responsibility, and accountability through employee engagement.
9. Lead lean manufacturing initiatives, evaluating and improving systems to reduce costs and waste while maximizing output.
10. Manage vendor and contractor supply chains, including pricing, service levels, and conflict resolution.
11. Maintain and report on inventory levels; implement tracking and shipping processes to ensure real-time, accurate information.
12. Support troubleshooting and problem-solving within teams; escalate issues as necessary.
13. Provide input on manufacturing feasibility for new product development.
14. Manage facilities and external service providers.

Job Requirements:

• University degree in engineering or manufacturing discipline.
• Lean and/or Six Sigma certification preferred.
• ERP training and certification, Oracle preferred.
• Training in quality, supply chain, or industrial management.
• Health and Safety certification.
• Minimum 5 years of hands-on manufacturing or operations management experience in the medical device or regulated high-tech industry.
• Strong time management and organizational skills with a sense of urgency.
• Proven focus on product quality, manufacturing processes, and policies; experience with NCRs, SCARs, and CAPA.
• Understanding of manufacturing strategies, supply chain, materials, and financial operations.
• Practical experience with lean principles, Design for Six Sigma, 5S, visual management, standardized work, and kaizen.
• Strong problem-solving skills for logistics, manufacturing, and technical issues.
• Successful track record in team engagement and leadership.
• Excellent organizational skills, ability to multi-task and meet deadlines.
• Effective interpersonal skills, assertive communication, and stakeholder collaboration.
• Proficiency in report writing and presentations.
• Ability to facilitate meetings and ensure timely information flow.
• Strong technical skills with ERP and MRP systems.
• Excellent written and oral communication skills.