Head of Quality - AVP

Head of Quality Assurance - AVP

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

• Strong 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

  1618 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.