Deskripsi Pekerjaan
We are seeking a meticulous Quality System Assurance Specialist to join our dynamic team in Bandung. In this critical role, you will design, implement, and validate comprehensive quality processes, procedures, and qualifications for all supporting systems, equipment, tools, and facilities. You will ensure product integrity by maintaining rigorous quality standards while driving continuous improvement initiatives. Your expertise will be instrumental in conducting risk assessments, managing internal audits, and ensuring compliance with ISO standards and regulatory requirements. This position offers the opportunity to work in a collaborative environment where your analytical skills and attention to detail will directly contribute to organizational excellence.
As a key member of our quality management team, you will develop documentation protocols, investigate quality deviations, and implement corrective actions. You will collaborate with cross-functional departments to harmonize quality systems across manufacturing and operational processes. The ideal candidate will thrive in a fast-paced setting where precision, problem-solving, and proactive quality management are paramount to our success.
Tanggung Jawab
- Plan, design, and validate processes, procedures, and qualifications for systems/equipment/tools/facilities
- Conduct internal quality audits and compliance assessments against ISO standards
- Develop and maintain comprehensive quality documentation including SOPs and validation reports
- Investigate product non-conformances and implement root cause analysis
- Coordinate with cross-functional teams to integrate quality requirements into product lifecycle
- Monitor and report on key quality metrics and performance indicators
- Ensure alignment with regulatory requirements and industry best practices
- Lead continuous improvement initiatives for quality management systems
Kualifikasi
- Bachelor's degree in Engineering, Quality Management, or related technical field
- Minimum 3 years of experience in quality assurance or quality systems management
- Strong knowledge of ISO 9001, GMP, and other quality management frameworks
- Experience with process validation protocols and qualification methodologies
- Proficiency in quality management software and documentation systems
- Certified Quality Manager (CQM) or Six Sigma certification preferred
- Excellent analytical skills with attention to detail and problem-solving abilities
- Strong communication skills for cross-functional collaboration