Quality Management System (QMS) Engineer

Pma Manufacturing Sdn Bhd; George Town; On-site; MYR 150,000 - 200,000; Full time

Job summary

An established industry player is seeking a dedicated QMS Engineer to oversee and enhance their Quality Management System. This role is pivotal in ensuring compliance with international standards and internal policies while fostering continuous improvement. The successful candidate will manage QMS documentation, coordinate audits, and implement safety regulations to maintain a safe workplace. If you have a passion for quality assurance and a strong background in engineering or quality management, this position offers an exciting opportunity to make a significant impact in a dynamic manufacturing environment.

Qualifications

• Minimum 3 years of experience in QMS, preferably in manufacturing.
• Familiarity with ISO 9001, ISO 13485, FDA, MDA, GMP standards.

Responsibilities

• Manage development and improvement of QMS processes.
• Conduct factory audits to ensure operational compliance.
• Implement health and safety policies for a safe environment.

Skills

Quality Management Systems (QMS)

ISO 9001

ISO 13485

FDA Compliance

GMP Standards

Safety Management

Microsoft Office Suite

Problem-Solving Skills

Communication Skills

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Quality Management

Tools

QMS Software Tools

Job description

Quality Management System (QMS) Engineer

We are seeking a dedicated and detail-oriented QMS Engineer to oversee and maintain the Quality Management System (QMS), ensuring compliance with relevant standards and continuous improvement.

This role will ensure compliance with international standards, internal policies, and customer requirements. In addition to QMS responsibilities, the QMS Engineer will also oversee safety-related matters to ensure workplace health and safety compliance.

Key Responsibilities:

Quality Management System (QMS) Maintenance & Compliance:

Manage the development, implementation, and continuous improvement of QMS processes across our organization.

Ensure alignment with relevant standards (such as ISO 9001, 13485, FDA, MDA, GMP) and other relevant industry standards.

Coordinate and lead internal and external audits, including corrective actions and preventive measures.

Ensure documentation control and timely updates to quality procedures, manuals, and work instructions.

Document Control & Management:

Manage and maintain all documents related to QMS and other compliance frameworks adopted by PMA Manufacturing Sdn Bhd.

Collaborate with various departments to ensure proper documentation and version control.

Develop tracking mechanisms to ensure timely reviews and updates to critical documents.

Factory Audits & Inspection:

Conduct factory audits to ensure operational compliance with company policies and standards.

Monitor quality metrics and provide reports with actionable management insights.

Coordinate with cross-functional teams to address non-conformance and initiate corrective actions.

Safety Management & Compliance:

Implement and maintain the company’s health and safety policies to ensure a safe working environment.

Ensure compliance with workplace safety regulations and guidelines.

Conduct regular safety inspections, risk assessments, and safety drills.

Manage and report incidents, including investigations and corrective actions to prevent recurrence.

Requirements:

Bachelor’s degree in Engineering, Quality Management, or a related field.

Minimum 3 years of experience in QMS, preferably within a manufacturing environment.

Familiarity with relevant standards (eg, ISO 9001, ISO 13485, FDA, MDA, GMP) and other relevant certifications.

Experience with safety management and workplace safety regulations.

Excellent communication and problem-solving skills.

Proficiency in Microsoft Office Suite and QMS software tools.

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Your application will include the following questions:

What's your expected monthly basic salary? Which of the following types of qualifications do you have? How many years' experience do you have as a Quality Management Engineer? Have you worked in a role which requires a sound understanding of ISO 9001? How many years of auditing experience do you have? Which of the following Microsoft Office products are you experienced with? How much notice are you required to give your current employer?

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