Senior Quality Assurance Manager
2 weeks ago
Job Title: QA Manager (ISO 13485 - Medical Devices/Pharmaceutical)
Overview:
Agensi Pekerjaan Minde Group Sdn Bhd, a leading manufacturer of pharmaceutical and medical packaging solutions, seeks a seasoned Quality Assurance Manager to join their team. The ideal candidate will possess strong leadership skills and expertise in ISO 13485 standards.
Key Responsibilities:
- Lead and manage the Quality Assurance department, ensuring compliance with ISO 13485 standards and regulatory requirements.
- Oversee the implementation and maintenance of the Quality Management System (QMS), including documentation, audits, and process improvements.
- Conduct internal and external audits, ensuring all operations meet 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.
Perks and Benefits:
- Competitive salary (MYR 9,000 to MYR 12,000 based on experience).
- Health insurance, performance bonuses, and opportunities for professional development.
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