Quality Compliance Specialist

6 days ago

Malaysia Masimo Full time

Job Summary:

The Quality Compliance Specialist investigates customer complaints, makes initial reporting decisions, facilitates investigations, and ensures completeness and consistency of the documentation for complaints.

Duties & Responsibilities:

  • Investigate complaints daily:
    • Responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow-ups, maintaining investigation records and all other supporting documentation, and assigning additional actions as necessary to close complaints.
    • Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.
    • Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; elevates complaints that require additional review for regulatory reporting.
    • Verifies that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generates additional complaint records to document all of the issues listed in the complaint description.
    • Ensures that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
    • Requests information from the customer related to complaints, including the return of product(s) that are part of a system (i.e. sensor-cable-monitor).
    • Reviews QPM trends related to complaints for potential trends.
    • Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
    • Evaluates each complaint to determine if an investigation is required. Where investigation is needed, determines timelines with Failure Analysis Lab to ensure timely evaluation of product complaints and timely completion of reports. Reviews complaint investigation reports to ensure investigations are thorough and adequate and in accordance with procedures.
    • Executes duties in compliance with established company policies.
    • Develops a thorough understanding of the complaint database.
  • Performs other duties or special projects as assigned.

Minimum Qualifications and Experience:

Minimum Qualifications:

  • Ability to follow instructions and procedures and prioritize tasks.
  • Ability to compile information, summarize, and input into quality databases.
  • Ability to interact effectively with internal and external stakeholders through phone calls, emails, and video meetings.
  • Fluent in English in writing and verbal communications.
  • Experience in Microsoft Suite applications.
  • Highly organized and self-motivated individuals.
  • Skills required:
    • Strong computer skills and expertise in Microsoft Office applications and charting programs.
    • Ability to interact effectively on a team and with internal and external customers.
    • Demonstrated excellent technical writing and verbal communication skills.
    • Demonstrated independent worker with ability to focus, and able to prioritize and handle multiple tasks and responsibilities.
    • Must be a self-starter, a “hands-on” individual who enjoys challenges and is dedicated to getting the job done with minimal and/or no direction.
    • Demonstrated attention to detail, strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
    • Logical approach to decision making.

Physical Requirements/Work Environment:

This position primarily works in an office environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid driver’s license is required.

The physical demands of the position described herein are essential functions of the job, and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level.

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