Head/Assistant Vice President - Quality

Job Summary:

- We are seeking a dynamic and experienced Head of Quality Assurance to lead and manage the Quality Assurance function at our large-scale latex examination glove manufacturing unit in Indonesia.

- This position plays a critical role in ensuring product quality, regulatory compliance, and continuous improvement in line with international standards.

Key Responsibilities:

- Quality Management System (QMS)

- Establish, implement, and maintain ISO 13485, ISO 9001, and GMP-compliant quality systems.

- Lead audits and inspections (internal, external, and regulatory).

- Develop and enforce SOPs, batch release procedures, and documentation practices.

- Regulatory Compliance

- Ensure compliance with global standards such as:

- ISO 13485:2016 (Medical Devices QMS)

- US FDA 21 CFR Part 820 (Quality System Regulation)

- CE marking requirements (MDR)

- EN 455, ASTM D3578, and ASTM D6319

- Indonesian Ministry of Health standards

- Liaise with regulatory authorities and certification bodies.

- Process and Product Quality Control

- Oversee in-process and finished product inspection and testing protocols.

- Manage microbiological and physical testing laboratories.

- Approve product release and manage product traceability.

- Continuous Improvement & Risk Management

- Drive CAPA, Root Cause Analysis (RCA), and non-conformance investigations.

- Implement SPC, Six Sigma, and Lean tools for process optimization.

- Ensure quality risk management and preventive measures are in place.

- Team Leadership and Training

- Lead a large team of QA/QC professionals and technicians.

- Foster a quality-first culture across production and support departments.

- Conduct regular training on quality standards and compliance.

Key Qualifications:

- Masters or Bachelor's Degree in Engineering, Chemistry or related field.

- Minimum 16- 18 years of experience in quality roles within latex glove or medical device manufacturing.

- Proven experience managing QMS in large manufacturing setups (>100 million gloves/month capacity).

- Strong knowledge of international regulatory and industry standards.

- Certifications such as Lead Auditor for ISO 13485 or Six Sigma Black Belt are preferred.

- Excellent communication and stakeholder management skills.

Preferred Attributes:

- Hands-on experience with automated glove manufacturing lines.

- Experience in greenfield project setup or large plant scale-up.

- Fluency in Bahasa Indonesia and English