Remediation Complaint Analyst – Medical Devices at QvalFocus Inc.

We’re looking for an experienced Complaint Analyst to support complaint handling, investigations, and post-market surveillance for a US medical device client.What we’re looking for:10+ years of experience in medical device/pharma complaint handling, PMS, or QAStrong knowledge of FDA 21 CFR Part 820 & ISO 13485Experience with (FDA 483 remediation or EU MDR remediation)Hands-on experience with complaint systems such as TrackWise, Veeva, Salesforce, or similarComplaint investigation, documentation, classification & IMDRF codingUnderstanding of MDR/Vigilance reporting, CAPA, RCA, and complaint trendingStrong analytical, technical writing, and cross-functional communication skillsBachelor’s degree in Engineering, Life Sciences, Biomedical, or related disciplineIf you have strong medical device complaint investigation/remediation experience and are open to a long-term remote opportunity, we’d love to connect!Interested? DM me or share your resume at rajnikanth@qvalfocus.com for consideration.

Remediation Complaint Analyst – Medical Devices

Emma

Responsibilities

Skills wanted:

Language(s) required:

Rajnikanth Maddi

Rajnikanth Maddi

About QvalFocus Inc.:

mission:

qvalfocus.com/

Admin access needed