$62,000 - 75,000 yearly
Number of Applicants
:000+
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Your main responsibilities as a Quality Operations Specialist:
· Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
· Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
· Assist complaint intake group through review and verification of initial complaint coding.
· Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections.
· Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.
What we are looking for in a Quality Operations Specialist:
· Bachelor’s Degree in Biomedical, Natural Sciences, Engineering or related fields
· Years’ Experience: 0-2 years
· Strong computer skills (including Excel)
· Demonstrated written and verbal communication skills
Familiarity with medical device complaint files and quality records;
· Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);.
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