Head Hunter India is seeking a dynamic and experienced Head of Quality Assurance - AVP to lead and manage the Quality Assurance function at a large-scale latex examination glove manufacturing unit in Indonesia. This pivotal leadership 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 and manage audits and inspections (internal, external, and regulatory).
- Develop and enforce Standard Operating Procedures (SOPs), batch release procedures, and comprehensive documentation practices.

Regulatory Compliance

- Ensure full compliance with global standards, including:
- ISO 13485:2016 (Medical Devices Quality Management System)
- US FDA 21 CFR Part 820 (Quality System Regulation)
- CE marking requirements (Medical Device Regulation - MDR)
- EN 455, ASTM D3578, and ASTM D6319
- Indonesian Ministry of Health standards
- Liaise effectively 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 to ensure accurate and reliable results.
- Approve product release and manage comprehensive product traceability systems.

Continuous Improvement & Risk Management





- Drive CAPA (Corrective and Preventive Action), Root Cause Analysis (RCA), and non-conformance investigations.
- Implement Statistical Process Control (SPC), Six Sigma, and Lean tools for ongoing process optimization.
- Ensure robust quality risk management and preventive measures are consistently in place.

Team Leadership and Training

- Lead and mentor a large team of QA/QC professionals and technicians.
- Foster a strong quality-first culture across all production and support departments.
- Conduct regular training on quality standards and compliance to enhance team capabilities.

Skills

- Solid knowledge of international regulatory and industry standards.
- Excellent communication and stakeholder management skills.
- Hands-on experience with automated glove manufacturing lines is preferred.
- Experience in greenfield project setup or large plant scale-up is preferred.
- Fluency in Bahasa Indonesia and English is preferred.

Qualifications

- Education: Bachelor's or Master's Degree in Engineering, Chemistry, Microbiology, or a related field.
- Experience: Minimum 16–18 years of experience in quality roles within latex glove or medical device manufacturing.
- Proven experience managing QMS in large manufacturing setups (with a capacity exceeding 100 million gloves/month).
- Certifications: Lead Auditor for ISO 13485 or Six Sigma Black Belt are preferred.

📌 Head of Quality - AVP (India)
🏢 Head Hunter India
📍 India