Quality Assurance Specialist
2 weeks ago
This position requires a Quality Assurance Specialist to oversee the implementation and maintenance of product inspection and release processes, ensuring compliance with country-specific labeling regulations. The role involves managing and tracking quality holds, driving improvements for 3PL Quality Management Systems and agreements, and coordinating rework activities and internal complaints.
- Implement and maintain product inspection and release processes
- Maintain compliance with country-specific labeling regulations
- Manage and track quality holds in 3PL
- Drive improvements for 3PL Quality Management Systems and agreements
- Coordinate rework activities and internal complaints
The successful candidate will also be responsible for acting as a quality engineer for APAC labeling and quality documentation, maintaining supplier qualifications, and supporting new supplier onboarding.
- Act as quality engineer for APAC labeling and quality documentation
- Maintain supplier qualifications and support new supplier onboarding
In addition, the Quality Assurance Specialist will participate in audits, own and manage NCR, CAPA, and PRA, assess quality system impacts, and provide feedback.
- Participate in audits and address audit requests
- Own and manage NCR, CAPA, and PRA
- Assess quality system impacts and provide feedback
To be successful in this role, the ideal candidate should have a minimum of 5 years' experience in quality/manufacturing within the medical device industry, strong knowledge of ISO 13485 and regulatory requirements, proficient in MS Office Suite, and strong communication, problem-solving, and critical thinking skills.
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