Senior Quality Assurance Manager

2 weeks ago


Johor Bahru, Johor, Malaysia Agensi Pekerjaan Minde Group Sdn Bhd Full time

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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