Analysis Skills, Cross-Functional, Discrepancy Report, Inventory Management, Maintain Compliance, Medical Equipment, Product Testing, Quality Assurance Methodology, Quality System Requirements (QSR), Regulatory Requirements, Root Cause Analysis, Shipping/Receiving, Systems Maintenance, Testing, Time Management
Required Skills:
- Product Inspection & Testing
- Complaint Handling
- Product Analysis
- Inventory Management
- Shipping & Receiving
- Documentation & Reporting
- Microsoft Office (Word, Excel, PowerPoint)
- Attention to Detail
- Problem Solving
- Cross-functional Collaboration
Preferred Skills:
- Medical Device Industry Experience
- FDA 21 CFR Part 820
- ISO 13485
- ISO 14971
- EU MDR (2017/745)
- IEC 60601
- Quality Systems
- Regulated Manufacturing Environment
Education:
- High School Diploma required.
- Vocational, technical education, or certification is preferred.
Experience:
- 4+ years of relevant experience in quality, laboratory, manufacturing, or product analysis.
- Experience with medical device complaint handling and regulated manufacturing environments is preferred.
Description:
- Inspect, test, and evaluate returned medical devices as part of the complaint handling process.
- Register returned products in the global complaint handling database.
- Manage inventory, shipping, receiving, labeling, packaging, and handling of returned medical devices.
- Investigate discrepant receipts and resolve inventory-related issues.
- Perform product testing following established work instructions and quality procedures.
- Identify product failures, determine potential root causes, and document objective evidence.
- Prepare product analysis reports and accurately document testing results.
- Support complaint investigations and collaborate with cross-functional teams to ensure timely resolution.
- Assist in improving testing methods, procedures, tools, and quality processes.
- Maintain compliance with quality systems and regulatory requirements.
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Three Point Solutions, Inc.