
Quality Compliance Specialist
The Quality Compliance Specialists investigate customer complaints, make initial reporting decisions, facilitate investigations, and ensure completeness and consistency of the documentation for complaints. Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics. Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description. Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file. Review QPM trends related to complaints for potential trend. Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
4+ Years of experience processing complaints in an FDA industry
Prior experience with MedWatch and other global regulatory reporting requirements for medical devices(e.g. MDRs, Vigilance reports, etc.) is desirable
Ability to interact effectively on a team and with internal and external customers.
Customer Relationship Management
Time Management
MS Word
MS Outlook
Technical writing skills
MS Excel skills
Process Improvement
Verbal communication
detail-oriented
written communication
Self-Driven
According to JobzMall, the average salary range for a Quality Compliance Specialist in 52 Discovery, Irvine, CA 92618, USA is between $62,000 and $84,000 per year. This range depends on factors such as experience, qualifications, and certifications. Additionally, salaries can vary depending on the size of the company and the industry in which it operates.
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Masimo is an American Irvine, California-based manufacturer of noninvasive patient monitoring technologies. The company sells more pulse oximetry to hospitals than any other company.

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