Complaint Analyst - Medical Devices
Location : Caldwell NJ US 07006
Job Type : Temp/Contract
Reference Code : 20383-BZ1
Compensation : open - 25-30/h
Start Date : 12/07/2020
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Science or Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Complaint Analyst to provide support and assistance in the evaluation of Product Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports.
- Responsible for reporting of complaints and processing of trending analysis in accordance with Corporate, Site, and department procedures, and regulatory requirements.
- Interact with medical professionals to support in the complaint investigations.
- Work in a team environment with members of the QA-Product Surveillance group on achieving team metrics requirements.
- Work independently and with different parts of the organization to resolve complex issues.
- Identifies and assesses new opportunities for improvements to work processes.
- Gathers and reports various complaints metrics. Present critical information at Complaint Reviews.
- Have good computer and data analysis skills.
- Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries.
- Has conceptual understanding of QA functions.
- Investigates and processes product complaints while maintaining compliance to all regulations.
- Investigation and documentation of field clinical events and follow-up with Sales Representatives.
- Accountable for compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV) and reportability requirements for various countries.
- Assisting with Product Field Actions as required.
- Maintenance of complaint handling site procedures.
- Collecting follow up information related to complaints from customers, typically through the Sales and Field Service groups.
Required Qualifications :
- BS in Science or Engineering.
- Minimum 3 years related experience in Quality Assurance.
- Prior experience performing product evaluation in a regulated industry is preferred.
- Knowledge in record keeping, computer software, laboratory procedures used for evaluation of samples, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations is preferred.
- Prior experience with the products and their usage is highly desirable.
- Must demonstrate effective written and verbal communication, including technical writing skills.
- Experience with SAP is preferred.
- Proficiency with Microsoft Office Products such as Word, Excel and PowerPoint or equivalent software applications is preferred.
Contact: Bill Zukowsky