Quality Compliance Specialists

Masimo.; Pasir Gudang; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading medical technology company is seeking a Quality Compliance Specialist to manage customer complaints and ensure compliance with FDA and international regulations. The ideal candidate will have experience in an FDA-regulated environment and strong skills in technical writing and communication. This role involves thorough investigation processes and maintaining quality records to uphold the company's commitment to excellence.

Qualifications

• Experience processing complaints in an FDA-regulated industry.
• Knowledge of Quality Systems and FDA regulations.
• Prior experience with MedWatch and global regulatory reporting is desirable.

Responsibilities

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

Skills

Computer skills

Technical writing

Communication

Attention to detail

Logical decision-making

Tools

Microsoft Office

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.

Duties & Responsibilities:

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 issues identified in the complaint description. If required, generates additional complaint records to document all 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 the complaint, 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. When needed, determines timelines with Failure Analysis Lab to ensure timely evaluation of product complaints and timely completion of reports. Reviews investigation reports to ensure investigations are thorough 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:

Experience processing complaints in an FDA-regulated industry.

Prior experience with MedWatch and other global regulatory reporting requirements for medical devices (e.g., MDRs, Vigilance reports, etc.) is desirable.

Comprehensive knowledge of Quality Systems, quality records, FDA regulations (21 CFR part 820 and Part 803), and ISO 13485 standard.

Skills required:

Strong computer skills and proficiency in Microsoft Office applications and charting programs.

Ability to interact effectively with a team and with internal and external customers.

Excellent technical writing and verbal communication skills.

Ability to work independently, focus, prioritize, and handle multiple tasks.

Self-motivated, proactive, and dedicated to completing tasks with minimal supervision.

Attention to detail, results-oriented, positive attitude, and a sense of urgency.

Logical decision-making approach.

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Manufacturing, Transport & Logistics 1,001-5,000 employees

Masimo (NASDAQ: MASI), headquartered in Irvine, California, is a fast-growing, award-winning international medical technology and device company with global operations. We develop innovative, noninvasive monitoring technologies that save, extend, and improve lives across all ages. Our technologies address challenging healthcare problems and aim to make blood monitoring less painful and more accessible. Innovation has been our passion for nearly 20 years.