6387 - QA Manager (ISO 13485 - Medical Devices/Pharmaceutical)
Agensi Pekerjaan Minde Group Sdn Bhd · Johor Bahru, Johor, Malaysia ·
- Category
- QA
- Experience
- 5+ years
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:
- 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.