
Quality Assurance Specialist
3 days ago
We are seeking a skilled professional to fill the role of Quality Systems Associate. This position is responsible for implementing and maintaining product inspection and release processes, as well as managing compliance with country-specific labeling processes. The ideal candidate will have strong knowledge of ISO 13485 and regulatory requirements, as well as proficiency in MS Office Suite. Additionally, they will possess strong communication, problem-solving, and critical thinking skills.
Key Responsibilities:
- Implement and maintain product inspection and release processes
- Maintain compliance with country-specific labeling processes
- Manage and track Quality Hold (Global & Local) in 3PL
- Drive improvements for 3PL Quality Management Systems and agreements
- Coordinate rework activities and internal complaints
- Perform First Article Inspection (FAI)
- Ensure warehouse compliance with procedures and work instructions
- Manage and follow up SCARs
Asia Pacific Quality Documentation & Supplier Management:
- Act as quality engineer for APAC labeling and quality documentation
- Maintain supplier qualifications and support new supplier onboarding
- Provide supplier quality training and implement supplier control processes
Post Market Quality Assurance:
- Maintain product complaint handling processes in APAC
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