QMS Engineer

Hirehub Management Sdn. Bhd.; Kulai; On-site; MYR 60,000 - 100,000; Full time

Job summary

An established industry player is setting up a new manufacturing facility focused on medical devices and precision engineering. They seek a skilled Quality Manager to develop and maintain their Quality Management System in compliance with ISO standards. This role involves ensuring product quality, leading ISO certification efforts, and providing training to employees on quality processes. The ideal candidate will have extensive experience in quality management within the molding industry and a strong understanding of medical plastics. Join this innovative company to make a significant impact in the medical device sector and enhance product quality.

Qualifications

• 5+ Jahre Erfahrung im Qualitätsmanagement, insbesondere in der Kunststoffverarbeitung.
• Starke Kenntnisse der ISO 13485 und relevanter ISO-Standards.

Responsibilities

• Entwicklung und Pflege des Qualitätsmanagementsystems gemäß ISO 13485.
• Durchführung interner Audits zur Sicherstellung der ISO-Compliance.

Skills

Qualitätsmanagement

ISO 13485

Medizinische Kunststoffe

Audits durchführen

Kommunikationsfähigkeiten in Mandarin

Education

Bachelor in Qualitätsingenieurwesen

Bachelor in Maschinenbau

Bachelor in Fertigungsingenieurwesen

Job description

A new manufacturing facility is being established in Senai Ipark, Johor Bahru, specializing in medical devices, injection molding, and precision engineering. We welcome talent with relevant industry experience to apply. For the right candidate, our client is prepared to offer up to a 30% increase on your current salary.

Job Description:

1. QMS Development & Maintenance:

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and other relevant ISO standards.
• Ensure that all QMS documentation, including policies, procedures, and work instructions, are up-to-date and effectively implemented.

2. Medical Plastics & Molding Expertise:

• Utilize your expertise in medical plastics to ensure that all products are manufactured in compliance with industry standards and regulatory requirements.
• Oversee the quality aspects of the molding process to ensure consistency and reliability in product quality.

3. ISO Compliance & Certification:

• Lead the company’s efforts to achieve and maintain ISO 13485 certification, as well as compliance with other relevant ISO standards for medical products.
• Conduct internal audits to assess compliance with ISO standards and identify areas for improvement.
• Drive continuous improvement initiatives within the QMS to enhance product quality, reduce defects, and increase efficiency.
• Collaborate with production, engineering, and quality teams to implement corrective and preventive actions (CAPAs) based on audit findings and quality data.

4. Regulatory & Customer Compliance:

• Ensure that all products meet regulatory requirements and customer specifications, particularly for medical devices and products.
• Liaise with regulatory bodies and customers during audits and inspections.

5. Training & Support:

• Provide training and support to employees on QMS processes, ISO standards, and quality-related topics.
• Foster a culture of quality and compliance throughout the organization.

6. Documentation & Reporting:

• Maintain accurate and detailed records of all quality-related activities, including audit reports, non-conformances, and CAPAs.
• Prepare regular reports on QMS performance, highlighting key metrics and areas for improvement.
• Identify and assess risks related to product quality and regulatory compliance, and develop strategies to mitigate these risks.
• Implement and monitor risk management processes in accordance with ISO standards.

Job Requirements:

• Bachelor's degree in Quality Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field.
• A minimum of 5 years of experience in quality management, particularly within the molding and plastic manufacturing industry.
• Expertise in medical plastics is a significant advantage.
• Strong knowledge of ISO 13485 and other relevant ISO standards related to medical products (e.g., ISO 14971, ISO 9001).
• Fluent in Mandarin, both written and spoken, to effectively communicate with Mandarin-speaking stakeholders.