Complaint Analyst

Cala Health; San Mateo (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Cala Health is seeking a detail-oriented Complaint Analyst to own the complaint lifecycle, investigate returned devices, and uncover trends that elevate our Quality Management System. You’ll triage, log in Arena, and perform root-cause analyses to drive improvements in our medical device manufacturing process.

The role emphasizes strong analytical skills, solid communication, and strict adherence to regulatory deadlines, with on-site work and full-time exempt status.

Qualifications

• Associate or bachelor’s degree in an engineering or technical discipline.
• Experience with SQL and Python for querying databases, aggregating sparse records, and performing statistical analysis.
• Experience with QMS concepts and the role of quality assurance in the medical device manufacturing environment is highly desired.
• Strong written and verbal communication skills, analytical reasoning, attention to detail, and the ability to prioritize tasks to meet strict regulatory deadlines.

Responsibilities

• Triage complaints and log into QMS (Arena) to prevent backlogs.
• Investigate returned devices and perform root cause analyses.
• Analyze trends, monitor metrics, and identify process improvements.
• Prepare reports summarizing findings for leadership review.
• Ensure compliance with QMS principles and FDA regulations throughout lifecycle.
• Contribute to continuous improvement and timely case closures.

Skills

SQL

Python

Statistical analysis

Analytical reasoning

Attention to detail

Task prioritization

Education

Bachelor's degree in engineering or technical discipline

Associate degree (optional)

Tools

Arena

QMS concepts

FDA regulations

Job description

About Cala 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.

Title: Complaint Analyst
Reports to: Quality Engineer
Location: Onsite, 5 days a week
Employment type: Full-Time, Exempt
Pay range: $70,000 - $90,000

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.

Skills and Experience Required

• 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.
• Experience with QMS concepts and the role of quality assurance in the medical device manufacturing environment is highly desired.
• Strong written and verbal communication skills, analytical reasoning, attention to detail, and the ability to prioritize tasks to meet strict regulatory deadlines.

Physical Demands: 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. Sponsorship decisions are made individually based on role, timeline, and cost considerations, and are not guaranteed. Cala Health believes our success is based on diversity of people, teams and thinking. We offer all employees the tools, training and mentoring they need to succeed. Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-jobrelated disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.