Complaint Analyst
About The Position
At Cala, we’re working to free people from the burden of chronic disease. We began by creating the first non-invasive prescription therapy for hand tremor. After years of careful fine-tuning and improvements, we released Cala kIQ — our most sophisticated therapy yet. Our products have empowered thousands of people to get back to their lives with confidence and ease. But we won’t stop there. Our pioneering technology can be applied across neurology, cardiology, and so much more. It’s all part of our mission to help people in their struggle with chronic disease. We’re only just getting started. The Opportunity Turn quality insights into action. We’re looking for a sharp, detail-oriented Complaint Analyst to own the complaint lifecycle, investigate returned products, and uncover trends that elevate our Quality Management System (QMS) A Day in the Life Complaint Triage & QMS Logging: Review inbound feedback to determine if issues meet formal complaint criteria. Accurately enter details into Arena to prevent backlogs and ensure seamless tracking. Hands-On Device Investigation: Safely process and inspect returned devices, executing thorough physical analyses to identify primary failure modes and root causes. Data Analytics & Trend Tracking: Monitor return rates and complaint metrics to spot emerging patterns, evaluate product performance, and uncover process improvement opportunities. Management Reporting: Synthesize technical findings, trend reports, and metric summaries into clear reports for leadership review. QMS & Regulatory Compliance: Apply foundational Quality Management System principles, strictly adhering to internal SOPs and FDA regulations throughout every stage of the lifecycle. Continuous Improvement: Identify operational inefficiencies and offer constructive, actionable feedback to elevate team standards and overall quality. Timely Case Closure: Maintain rigorous documentation standards and attention to detail to execute precise, compliant, and timely file closures.
Requirements
- Associate or bachelor’s degree in an engineering or technical discipline.
- Understanding of SQL, Python for querying databases, aggregating sparse records, and performing statistical analysis.
- Strong written and verbal communication skills, analytical reasoning, attention to detail, and the ability to prioritize tasks to meet strict regulatory deadlines.
- Ability to lift, move, and handle package returns and testing objects weighing up to 20 pounds.
- Applicants must be authorized to work in the United States on a full-time basis, or eligible for work authorization through a sponsorship path that Cala Health is able to support.
Nice To Haves
- Experience with QMS concepts and the role of quality assurance in the medical device manufacturing environment is highly desired.
Responsibilities
- Review inbound feedback to determine if issues meet formal complaint criteria.
- Accurately enter details into Arena to prevent backlogs and ensure seamless tracking.
- Safely process and inspect returned devices, executing thorough physical analyses to identify primary failure modes and root causes.
- Monitor return rates and complaint metrics to spot emerging patterns, evaluate product performance, and uncover process improvement opportunities.
- Synthesize technical findings, trend reports, and metric summaries into clear reports for leadership review.
- Apply foundational Quality Management System principles, strictly adhering to internal SOPs and FDA regulations throughout every stage of the lifecycle.
- Identify operational inefficiencies and offer constructive, actionable feedback to elevate team standards and overall quality.
- Maintain rigorous documentation standards and attention to detail to execute precise, compliant, and timely file closures.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
