Quality Assurance Technician
Roles & Responsibilities
- This position is responsible for conducting routine inspection and analysis of incoming service material and quality reviews of domestic and international service records by identifying conflicts, dependencies, and risk of release to ensure Quality Assurance Standards and procedures are met.
- Material Review Support – May be asked to support investigation of electrical/electronic or mechanical parts to determine root causes of failures and to assist with dispositions of failed parts.
Experience Required
NA
Skills & Certifications
- Accept or Reject products as defined in the inspection instruction/ checklist.
- Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations.
- Perform other duties as assigned.
Eligibilities & qualifications
- Excellent communication and team skills as well as a keen attention to detail
- Associate degree in a related technical field or equivalent experience
- Working knowledge of Microsoft Office Suite, Excel, Word, etc.
- Operate to the requirements of FDA 21 CFR Part 820 and ISO 13485
- Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)
- Familiar with a variety of measurement equipment
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