Complaint Specialist, Post-Market Surveillance
4 weeks ago
Summary
Our client, a Fortune 500 Medical Device Company, has engaged GForce Life Sciences to provide a complaint specialist. This position will report to a quality manager within the quality department.
Duties / Expectations of Role
- Assist team with complaint investigations which can involve risk assessments, complaint history review searches, and escalating to CAPA if necessary.
- Will review surgical techniques guides and create customer letters.
- Assist with front-end complaint-handling tasks.
- Assist with reviewing new complaints for accuracy and setting them up for future processing
- Completing diligence tasks to get products returned and updating complaints with any additional information received
- Transacting product returns and scrap while helping with initiation when customer service is short-staffed.
- Apply departmental procedures to the evaluation of complaint information for acceptable content and supporting data. Independently evaluate information, reports and data.
- Prepare complaint data summaries and trend reports regarding complaints and complaint process key performance indicators. Prepare complaint-related data for Management Review.
- Other duties and projects as may be assigned.
Mandatory Requirements
- B.S. Degree, preferably in Engineering
- 2+ years of prior complaint-handling experience with a medical device company
- Quality experience
Nice to Have
- Prior experience processing medical device complaints or quality assurance/regulatory affairs background
- Patient care experience
- Knowledge of 21 CFR 820 regulations and ISO 13485
- Decision Tree experience with complaints
- Proficient with use of complaint and quality-related IT systems and tools
Term & Start
- 3 months
- ASAP
- Full-time (40 hours/week)
- Possibility of extension
- Hybrid (Mon-Wed) in Parsippany, NJ
- Benefits included (Medical, Dental, Vision, 401k)
- Pay Rate - $30-34/hr
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