job description
Join Brosmed Medical (Malaysia) Sdn Bhd as a QA Supervisor in our expanding operations in Bali, Indonesia. This is a unique opportunity to lead quality assurance initiatives in the medical device manufacturing sector, ensuring compliance with international standards while driving operational excellence.
As a QA Supervisor, you will oversee a team of quality control professionals, implement robust testing protocols, and maintain the highest standards of product quality. Your expertise will be critical in upholding regulatory compliance (ISO 13485, FDA, CE) and fostering a culture of continuous improvement. With a competitive salary package and the chance to work in a dynamic, innovative environment, this role is perfect for a detail-oriented leader passionate about quality in healthcare manufacturing.
Bali offers a vibrant work-life balance, combining professional growth with a tropical lifestyle. Relocation assistance may be available for qualified candidates.
Responsibility
- Lead and supervise the QA team to ensure adherence to quality standards and regulatory requirements (ISO 13485, FDA, CE).
- Develop, implement, and maintain quality control systems, procedures, and documentation for medical device production.
- Conduct regular audits (internal/external) and identify areas for process improvement to enhance product quality and efficiency.
- Collaborate with cross-functional teams (Production, R&D, Engineering) to resolve quality issues and implement corrective actions.
- Monitor and analyze quality metrics, preparing reports for senior management and regulatory bodies.
- Train and mentor staff on quality protocols, GMP, and industry best practices.
- Ensure compliance with local and international medical device regulations and customer specifications.
- Drive continuous improvement initiatives (e.g., Lean, Six Sigma) to reduce defects and optimize processes.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field. Advanced degree is a plus.
- Minimum 5 years of experience in QA/QC within medical device or pharmaceutical manufacturing, with at least 2 years in a supervisory role.
- In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, CE Marking, and GMP standards.
- Strong leadership, communication, and problem-solving skills with the ability to manage teams effectively.
- Experience with root cause analysis (RCA), CAPA, and risk management (FMEA) tools.
- Proficiency in quality management software (e.g., SAP, TrackWise) and Microsoft Office Suite.
- Fluency in English (written and verbal); knowledge of Indonesian is advantageous.
- Willingness to relocate to Bali, Indonesia (relocation support may be provided).