job description
Join Right Recruit as a QA Manager (Quality Control) for a globally recognized leader in precision engineering and manufacturing, serving the medical devices and automotive industries. This is a unique opportunity to drive quality excellence in a high-impact role based in Bali, Indonesia.
In this position, you will oversee the development, implementation, and maintenance of Quality Management Systems (QMS) to ensure compliance with international standards such as ISO 13485 (Medical Devices) and IATF 16949 (Automotive). You will lead a team of quality professionals, collaborate with cross-functional departments, and drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
If you are a results-driven QA professional with a passion for precision and a track record in highly regulated industries, we invite you to apply and contribute to our mission of delivering world-class manufacturing solutions.
Responsibility
- Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485, IATF 16949, and other relevant industry standards.
- Lead and mentor a team of QA/QC professionals, ensuring adherence to quality protocols and best practices.
- Conduct internal and external audits to identify non-conformities and implement corrective/preventive actions (CAPA).
- Collaborate with R&D, Production, and Supply Chain teams to integrate quality controls into product development and manufacturing processes.
- Monitor and analyze quality metrics, KPIs, and defect trends to drive data-driven decision-making.
- Ensure compliance with regulatory requirements (e.g., FDA, CE Marking) for medical devices and automotive components.
- Spearhead continuous improvement initiatives (e.g., Lean, Six Sigma) to enhance product quality and reduce waste.
- Serve as the primary liaison for customer quality complaints and resolution, ensuring timely and effective responses.
Qualifications
- Bachelor’s degree in Engineering, Quality Management, or a related field. Master’s degree is a plus.
- Minimum 8+ years of experience in QA/QC, with at least 3 years in a managerial role within medical devices or automotive manufacturing.
- In-depth knowledge of ISO 13485, IATF 16949, FDA 21 CFR Part 820, and other relevant quality standards.
- Certified Lead Auditor (ISO 13485/IATF 16949) or Six Sigma Black Belt is highly desirable.
- Proven experience with CAPA, Root Cause Analysis (RCA), and statistical process control (SPC).
- Strong leadership, communication, and problem-solving skills with the ability to influence stakeholders at all levels.
- Familiarity with ERP/MES systems and quality software (e.g., SAP QM, ETQ Reliance).
- Fluency in English; additional language skills (e.g., Indonesian) are a plus.