Masimo

Quality Compliance Specialist

Masimo

52 Discovery, Irvine, CA 92618, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

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.

Where is this job?
This job is located at 52 Discovery, Irvine, CA 92618, USA
Job Qualifications
  • 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.

Required Skills
  • Customer Relationship Management

  • Time Management

  • MS Word

  • MS Outlook

  • Technical writing skills

  • MS Excel skills

Soft Skills
  • Process Improvement

  • Verbal communication

  • detail-oriented

  • written communication

  • Self-Driven

Compensation

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.

Additional Information
Masimo is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedApril 17th, 2021
Apply BeforeAugust 19th, 2025
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About Masimo

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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