Executive Quality Assurance

Perusahaan Getah Asas; Kuala Selangor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading manufacturing company in Kuala Selangor is seeking a candidate responsible for preparing Quality Management System documents for compliance with various ISO standards. The successful applicant will handle audits, streamline procedures, and ensure safety practices are followed. Ideal for individuals with a background in quality management and regulatory compliance.

Responsibilities

• Prepare QMS documents for compliance with ISO standards.
• Prepare EMS and OH&S MS documents.
• Review and update company procedures and work instructions.
• Handle internal and external audits.
• Compile data and quality trends for management reviews.
• Provide documentation for product registration and marketing requests.

Job description

Responsibilities

• Responsible for preparation of all Quality Management System (QMS) Document associated with the manufacture of medical devices to ensure compliance with ISO 13485, ISO 9001, cGMP, FDA and MDR guidelines.
• Responsible for preparation of Environmental Management System (EMS) and Occupational Health & Safety Management System (OH&S MS) Document.
• Assists in reviewing and / or updating company’s Procedures and Work Instructions.
• Assists in the preparation, coordinating and handling the internal and external audits.
• Assists in compiling data and quality trends for management reviews.
• Assists in compiling and providing the documentation on product registration and any other Marketing request.
• To observe the company policy.
• To follow the company safety rules and regulations in daily operation.
• To ensure proper GMP practice and safety practice.
• Other assigned duties as required by his/her superior.