Quality Compliance Specialist

Masimo; Pasir Gudang; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading company in the medical device industry is seeking a Quality Compliance Specialist to investigate customer complaints and ensure compliance with regulations. The role involves thorough documentation, effective communication with stakeholders, and maintaining high standards of quality in complaint handling. Ideal candidates will be highly organized, detail-oriented, and possess strong technical writing skills.

Qualifications

• Ability to follow instructions and prioritize tasks.
• Fluent in English, both written and verbal.
• Demonstrated independent worker with strong results orientation.

Responsibilities

• Investigate customer complaints and ensure compliance with regulations.
• Document initial reportability decisions and maintain investigation records.
• Evaluate complaints to determine if investigations are required.

Skills

Strong computer skills

Technical writing

Effective communication

Attention to detail

Tools

Microsoft Suite

Job description

Job Summary:

The Quality Compliance Specialist investigate customer complaints, make initial reporting decisions, facilitate investigations, and ensure 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 documentations, and assign additional actions as necessary to close complaint.
  • 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; Elevate complaints that require additional review for regulatory reporting.
  • 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.
  • Requests information from the customer related to complaint including the return of product(s) that are part of a system (i.e. sensor-cable-monitor).
  • 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.
  • Evaluates each complaint if an investigation is required or not. Where investigation is needed, determine 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.
• Perform 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 database.
• 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 challenge 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 validDriver’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