Quality Complaint Analyst - Medical Device QMS & Analytics

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

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.