Remote Complaint Analyst - Medical Device Industry
About the Role
We're hiring a Remote Complaint Analyst to join our innovative team at Calyxo, Inc. As a Complaint Analyst, you will play a crucial role in improving kidney stone treatment by managing and investigating customer complaints. This position is fully remote, allowing you to work from anywhere while contributing to a vital healthcare mission.
What You'll Do
- Receive and enter complaint data from Field Representatives and Customers into the quality system.
- Follow up with Field Representatives or Customers to gather additional information regarding complaints.
- Own and track complaints throughout the investigation process, ensuring thorough documentation.
- Facilitate complaint investigations, ensuring completeness and consistency of complaint files and records.
- Support post-market compliance activities, handling customer complaints in accordance with documented procedures.
- Evaluate complaints and perform preliminary investigations, including follow-ups with healthcare professionals and sales representatives.
- Escalate complaints involving new failure modes and collaborate with Engineering, Field Personnel, and Quality Assurance teams.
- Coordinate complaint investigation efforts with Quality and R&D teams, driving investigations to completion in a timely manner.
Requirements
- Experience with FDA Quality Management System Regulations.
- Strong analytical skills and attention to detail.
- Ability to perform effectively in a high-paced, dynamic environment.
- Excellent communication skills, both written and verbal.
- Proven experience in complaint handling or quality assurance in a healthcare setting.
Nice to Have
- Familiarity with medical device regulations and compliance.
- Experience working in a cross-functional team environment.
- Knowledge of complaint management software.
What We Offer
- Competitive salary ranging from $80,000 to $100,000 annually.
- Fully remote work environment with flexible hours.
- Opportunities for professional development and growth.
- A dynamic and diverse team atmosphere.
- Health and wellness benefits.
This Remote Complaint Analyst position at Calyxo offers a unique opportunity to impact healthcare positively while enjoying the flexibility of remote work.
Who Will Succeed Here
Strong understanding of FDA Regulations and quality assurance processes, with experience in complaint management using tools like CAPA (Corrective and Preventive Action) systems.
Self-motivated and detail-oriented, capable of managing multiple complaint cases simultaneously in a remote setting while maintaining high accuracy in data entry.
Analytical mindset with proficiency in data analysis tools such as Excel or statistical software to evaluate complaint trends and suggest improvements.
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