QA Manager

1 week ago


Serang, Indonesia HAP Indonesia - Your Reliable Hiring Partner Full time

**Our Client Company Type**: Healthcare & Life Science

**Working Location**: Jakarta & Cikande, Indonesia

**Employment Status**: Permanent

**Reporting Line**: report to the Plant Manager

**Salary**: up to IDR 15 Million per month

**Requirement**:
+ Having more than 5 years experience in develop, implement, monitor, and evaluate quality control (QC) processes to ensure compliance with standards and product quality in Medical Devices or Pharmaceuticals Manufacturing industry.

+ Conduct product testing, analyze results, and recommend improvements to meet specifications and regulatory requirements.

+ Manage non-compliant products by creating corrective action plans and ensuring issues are resolved and prevented.

+ Oversee ISO 13485 certification processes and ensure good manufacturing practices (GMP) are applied in medical device production.

+ Collaborate with R&D to align product development with quality standards and applicable regulations.

+ Coordinate with auditors and regulatory bodies to confirm compliance with medical device regulations.

+ Lead and mentor QA teams, plan and execute audits, and provide training to maintain high-quality standards.

+ Excellent leadership, communication & interpersonal skills, strategic management, strong analytical and problem-solving skills

+ Good English with minimum Bachelor Degree in Engineering, Pharmacy, Biology, Biotechnology, Chemistry or other related fields

**Education**:

- S1 (required)

**Experience**:

- Healthcare products QA: 5 years (required)

**Language**:

- English (required)


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