job description
Join a dynamic team in Bali as a Quality Assurance System Specialist, where you will play a pivotal role in ensuring the highest standards of product quality and operational excellence. This position involves planning, validating, and optimizing processes, procedures, and qualifications for supporting systems, equipment, tools, and facilities to guarantee compliance and efficiency.
As a key contributor, you will collaborate with cross-functional teams to implement robust quality management systems, conduct thorough audits, and drive continuous improvement initiatives. Your expertise will directly impact product integrity, regulatory adherence, and customer satisfaction in a fast-paced, innovative environment.
This is an exceptional opportunity for a detail-oriented professional with a passion for quality assurance to thrive in Bali’s growing industrial and manufacturing sector.
Responsibility
- Develop, implement, and maintain Quality Management Systems (QMS) in alignment with industry standards (e.g., ISO 9001, GMP).
- Plan and validate processes, procedures, and qualifications for equipment, tools, and facilities to ensure compliance and efficiency.
- Conduct internal and external audits to identify gaps and recommend corrective actions.
- Collaborate with production, engineering, and R&D teams to enhance product quality and consistency.
- Monitor and analyze quality metrics to drive data-driven improvements.
- Ensure adherence to regulatory requirements and company policies.
- Train and mentor staff on quality standards, protocols, and best practices.
- Document and report non-conformities, deviations, and CAPA (Corrective and Preventive Actions).
Qualifications
- Bachelor’s degree in Engineering, Quality Management, or a related field.
- Minimum 3+ years of experience in Quality Assurance, preferably in manufacturing or industrial sectors.
- In-depth knowledge of QMS frameworks (ISO 9001, ISO 13485, GMP, etc.).
- Strong analytical and problem-solving skills with attention to detail.
- Proficiency in audit techniques, root cause analysis (RCA), and statistical tools.
- Excellent communication and interpersonal skills to collaborate across departments.
- Familiarity with document control, risk management, and validation protocols.
- Certifications in Six Sigma, Lean, or Lead Auditor are a plus.