6387 - QA Manager (ISO 13485 - Medical Devices/Pharmaceutical)

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

Location: Johor Bahru

Company Overview:

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:

1. 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.
2. Oversee the implementation and maintenance of the Quality Management System (QMS), including documentation, audits, and process improvements.
3. Conduct internal and external audits, ensuring that all operations meet the required quality standards and regulatory guidelines.
4. Collaborate with the production and engineering teams to address and resolve quality issues.
5. Ensure product safety, efficacy, and compliance through rigorous quality control processes.
6. Train and mentor the QA team on ISO 13485 practices, continuous improvement initiatives, and corrective actions.
7. Manage customer audits and regulatory inspections, ensuring all findings are addressed promptly.

Requirements:

1. Bachelor's degree in Engineering, Quality Assurance, or a related field.
2. At least 5 years of experience in QA management, preferably in the medical device or pharmaceutical industries.
3. Strong knowledge of ISO 13485 and other relevant quality standards.
4. Proven track record in managing audits and maintaining a compliant QMS.
5. 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.