Mdr Complaint Handling Specialist
3 weeks ago
Here are the job position details for your review:
Job Title**:MDR Complaint Handling Specialist**
Pay Rate**:$35 to $39/HR**
Duration**:12 months**
Location**:Irvine, CA**
We are looking for **MDR Complaint Handling Specialist**
The main function of a **MDR Complaint Handling Specialist** is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
**Responsibilities**:
- Manage customer relationships and expectations during the course of the **complaint** **investigation** and resolution process
- Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering, and other departments/business units for complaint investigations
- **Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA**:
- Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable **root causes,** resolve open action items, and gather additional technical information to resolve the complaint
**Skills**:
- Experience working in a **medical device** (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
- Proven expertise in MS Office Suite and ability to operate general office machinery
**Education and Experience**:
- Bachelor's Degree or equivalent in a related field
- 1+ year of experience required
**Job Type**: Contract
Pay: $35.00 - $39.00 per hour
Expected hours: 40 per week
Experience level:
- 1 year
Schedule:
- 8 hour shift
Work setting:
- In-person
Ability to Commute:
- Irvine, CA 92614 (required)
Ability to Relocate:
- Irvine, CA 92614: Relocate before starting work (required)
Work Location: In person
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