Quality Assurance Supervisor

4 days ago

Semarang, Central Java, Indonesia Hirea Group Bhuana Full time $15,000 - $25,000 per year

Job Overview

We are looking for an experienced and proactive Quality Assurance Supervisor to lead and manage our Quality Management System. The ideal candidate is highly knowledgeable in medical device regulations, especially the requirements of the Indonesian BPOM, and possesses strong leadership and communication skills. You will be responsible for ensuring that our products meet the highest quality standards and comply with global regulatory requirements throughout their entire lifecycle.

Key Responsibilities

Quality Management System (QMS) Implementation & Maintenance

  • Lead, maintain, and continuously improve the QMS in compliance with ISO 13485, MDSAP, and Indonesian BPOM requirements
  • Manage internal and external audits (including supplier audits, notified body audits, and BPOM audits), and ensure proper follow-up of CAPA actions
  • Manage document control including quality manuals, SOPs, work instructions, and records

Regulatory Compliance

  • Serve as the primary contact with BPOM for product registration, change notifications, and regulatory communication
  • Monitor and interpret updates in medical device regulations in Indonesia and Southeast Asia
  • Lead compliance assessments for new product launches

Product Quality Control

  • Oversee incoming material inspection, in-process quality control, and final product inspection
  • Manage non-conformance processes including investigation, segregation, evaluation, and disposition
  • Lead CAPA implementation and apply root-cause analysis for continuous improvement

Risk Management

  • Implement and oversee medical device risk management in accordance with ISO 14971
  • Integrate risk management into product development and manufacturing processes

Team Leadership & Development

  • Recruit, guide, train, and develop the QA team to enhance capability and performance
  • Set clear team objectives and conduct regular performance evaluations

Continuous Improvement

  • Utilize quality metrics (e.g., customer complaints, defect rates, quality cost) to drive improvement initiatives
  • Promote a strong quality culture across the organization

Qualifications

Required:

  • Bachelor's degree or higher in Biomedical Engineering, Pharmacy, Biology, Chemistry, or related science/engineering fields
  • Minimum 5 years of experience in Quality Assurance in the medical device industry, including at least 2 years in a supervisory or team lead role

  • Strong knowledge and practical experience with:

  • ISO 13485

  • ISO 14971
  • Strong proficiency in English (written and spoken)

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