QA Manager (ISO 13485) — Medical Devices & Pharma

Agensi Pekerjaan Minde Group Sdn Bhd; Johor Bahru; On-site; MYR 100,000 - 134,000; Full time

Benefits offered by this job

Health insurance

Performance bonuses

Professional development

Job summary

Agensi Pekerjaan Minde Group Sdn Bhd partners with a leading Malaysian medical packaging manufacturer to hire a QA Manager (ISO 13485). The role leads the QA department to maintain regulatory compliance and product safety in a fast-paced environment.

The ideal candidate holds a bachelor’s degree in Engineering/QA with 5+ years in QA management, extensive ISO 13485 knowledge, and a proven audits track record. Competitive salary and benefits are offered.

Qualifications

• Bachelor's degree in Engineering, QA, or related field.
• 5+ years in QA management, preferably medical devices/pharma.
• Strong knowledge of ISO 13485 and regulatory guidelines.

Responsibilities

• Lead and manage the QA department ensuring ISO 13485 compliance.
• Oversee QMS implementation, audits, and process improvements.
• Conduct internal and external audits and ensure regulatory adherence.
• Collaborate with production and engineering to resolve quality issues.
• Ensure product safety and conformance through QC processes.
• Train and mentor QA team on ISO 13485 practices and improvements.
• Manage customer audits and regulatory inspections.

Skills

Leadership

Communication

Education

Bachelor's degree in Engineering/QA

Job description

Agensi Pekerjaan Minde Group Sdn Bhd partners with a leading Malaysian medical packaging manufacturer to hire a QA Manager (ISO 13485). The role leads the QA department to maintain regulatory compliance and product safety in a fast-paced environment.

The ideal candidate holds a bachelor’s degree in Engineering/QA with 5+ years in QA management, extensive ISO 13485 knowledge, and a proven audits track record. Competitive salary and benefits are offered.