Job Description

Job Title: QA Manager (ISO 13485 - Medical Devices/Pharmaceutical)

Location: Johor Bahru

A leading manufacturer of pharmaceutical and medical packaging solutions, this company specializes in providing high-quality, customized packaging for the healthcare sector. They are well-established in Malaysia and Singapore and are known for their commitment to innovation and compliance with international standards such as ISO 13485.

Job Responsibilities:

• Lead and manage the Quality Assurance (QA) department, ensuring compliance with ISO 13485 standards and other regulatory requirements specific to the medical device and pharmaceutical industries.
• Oversee the implementation and maintenance of the Quality Management System (QMS), including documentation, audits, and process improvements.
• Conduct internal and external audits, ensuring that all operations meet the required quality standards and regulatory guidelines.
• Collaborate with the production and engineering teams to address and resolve quality issues.
• Ensure product safety, efficacy, and compliance through rigorous quality control processes.
• Train and mentor the QA team on ISO 13485 practices, continuous improvement initiatives, and corrective actions.
• Manage customer audits and regulatory inspections, ensuring all findings are addressed promptly.

Requirements:

• Bachelor's degree in Engineering, Quality Assurance, or a related field.
• At least 5 years of experience in QA management, preferably in the medical device or pharmaceutical industries.
• Strong knowledge of ISO 13485 and other relevant quality standards.
• Proven track record in managing audits and maintaining a compliant QMS.
• Excellent communication and leadership skills, with the ability to collaborate across departments.

This role is ideal for a quality professional with experience in the medical or pharmaceutical industries, looking to ensure the highest standards of product safety and compliance in a dynamic environment.