Deskripsi Pekerjaan
Join Boston Scientific as a Quality Technician and play a pivotal role in maintaining our world-class manufacturing standards. In this position, you'll be responsible for monitoring and controlling critical quality documentation systems, ensuring full compliance with international quality standards. You'll manage exception reports, non-conformance reports, and conduct rigorous line audits to identify process improvements. This role offers the opportunity to work in a dynamic environment where precision and attention to detail directly impact patient safety and product efficacy. As part of our quality assurance team, you'll collaborate with cross-functional departments to implement corrective actions and drive continuous improvement initiatives. Boston Scientific provides comprehensive training and career development opportunities for quality professionals looking to advance their careers in the medical device industry.
Tanggung Jawab
- Manage and control closed Exception Reports and Non-Conformance Reports (NCRs)
- Conduct comprehensive line audits to ensure process compliance
- Maintain and update Nonconforming Report Board Reports
- Implement corrective and preventive actions for quality issues
- Document quality control activities and maintain audit trails
- Analyze quality data trends to identify improvement opportunities
- Collaborate with production teams to resolve quality-related concerns
- Ensure adherence to ISO 13485 and other regulatory standards
Kualifikasi
- Diploma or Degree in Engineering, Quality Management, or related field
- Minimum 2-3 years of experience in quality control or manufacturing
- Familiarity with ISO 13485 and GMP standards
- Proficiency in quality management systems (QMS) software
- Strong analytical and problem-solving skills
- Certification in Six Sigma or Quality Auditing (preferred)
- Excellent attention to detail and documentation skills
- Ability to work independently and in cross-functional teams