job description
Join a leading medical manufacturing company as a Quality Manager and play a pivotal role in ensuring the highest standards of quality for life-saving medical devices. Based in the vibrant regions of Bali, you will lead a dedicated quality team, driving continuous improvement initiatives to enhance product excellence and regulatory compliance.
This is a unique opportunity to work in a dynamic environment where innovation meets precision. You will collaborate with cross-functional teams to implement best practices, conduct rigorous quality audits, and ensure adherence to international standards such as ISO 13485 and FDA regulations. The role offers competitive benefits, professional growth, and the chance to make a meaningful impact in the healthcare industry.
If you are a passionate quality professional with a keen eye for detail and a commitment to excellence, we invite you to apply and be part of our mission to deliver cutting-edge medical solutions.
Responsibility
- Lead and manage the quality assurance team to ensure compliance with industry standards and regulations.
- Develop and implement quality control processes and procedures for medical device manufacturing.
- Conduct regular audits and inspections to identify areas for improvement and ensure product quality.
- Collaborate with production, engineering, and R&D teams to resolve quality issues and drive continuous improvement.
- Oversee the documentation and reporting of quality metrics, non-conformances, and corrective actions.
- Ensure adherence to ISO 13485, FDA, and other relevant regulatory requirements.
- Train and mentor staff on quality standards, best practices, and compliance protocols.
- Participate in risk management activities and contribute to the development of quality policies.
Qualifications
- Bachelor's degree in Engineering, Quality Management, or a related field.
- Minimum of 5 years of experience in quality management within the medical device or pharmaceutical industry.
- Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
- Proven experience in leading quality teams and implementing quality management systems.
- Excellent analytical, problem-solving, and communication skills.
- Certification in Quality Management (e.g., CQM, Six Sigma) is a plus.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Familiarity with lean manufacturing and continuous improvement methodologies.