Deskripsi Pekerjaan
Join our dynamic team as a Quality Management Specialist / QMS ISO 13485 and play a pivotal role in ensuring excellence in medical device manufacturing. As a key member of our quality assurance team, you will be responsible for implementing, maintaining, and continuously improving our Quality Management System (QMS) in accordance with ISO 13485 standards.
ISO 13485 is the internationally recognized Quality Management System standard specifically designed for the medical device and medical technology industry. This position offers an exciting opportunity to work in a regulated environment where quality is paramount. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements, drive process improvements, and maintain documentation that meets the highest industry standards.
We are looking for a detail-oriented professional with a passion for quality and continuous improvement. If you thrive in a fast-paced manufacturing environment and are committed to excellence, this role offers excellent career growth opportunities in the thriving medical device sector.
Tanggung Jawab
- Implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with ISO 13485 standards
- Develop, review, and update quality documentation including procedures, work instructions, and forms
- Conduct internal audits to ensure compliance with quality standards and regulatory requirements
- Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions
- Manage supplier quality assurance processes and conduct supplier evaluations
- Coordinate with regulatory affairs to ensure compliance with local and international regulations
- Train staff on quality procedures and best practices
- Monitor quality metrics and report on system performance to management
Kualifikasi
- Degree or Diploma in Engineering, Quality Management, or related field
- Certification in ISO 13485 Quality Management Systems
- Minimum 3 years of experience in quality management, preferably in medical device manufacturing
- Strong knowledge of ISO 13485 standards and regulatory requirements
- Experience with internal auditing and quality management systems
- Excellent analytical and problem-solving skills
- Strong attention to detail and documentation skills
- Good communication and interpersonal skills