layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Complaint Analyst at Cala Health | LAYIQ

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.

Complaint Analyst

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