Post-Market Quality & Complaint Investigator

iRhythm Technologies, Inc.; Iloilo; On-site; PHP 480,000 - 720,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Quality Assurance/Complaints Specialist in Iloilo.

The role focuses on evaluating complaints for regulatory reporting, coordinating investigations with cross-functional teams, and maintaining thorough records to support ISO 13485 and FDA/EU compliance. The ideal candidate has 3–5 years in QA or complaint processing in medical devices, strong problem-solving, and solid technical writing abilities.

Qualifications

• Bachelor’s or Associate Degree in science, technology, or medical fields.
• 3–5 years of QA and/or complaint processing experience.
• Experience in medical devices; knowledge of ISO 13485, FDA 21 CFR 820, EU MDD/MDR is a plus.
• Strong problem-solving, critical thinking, and investigation skills.
• Ability to work across functional teams and articulate findings in writing.

Responsibilities

• Evaluate complaints for reportability per 21 CFR Part 803 and related standards.
• Coordinate investigations and gather information with other departments.
• Assess information from a technical perspective to ensure complete analysis.
• Escalate issues in a timely manner and maintain the complaints log.
• Participate in process improvements and other quality/regulatory duties.

Skills

Quality Assurance

Complaint processing

Regulatory awareness

Technical writing

Cross-functional teamwork

Education

Bachelor’s/Associate degree in science/tech/medical fields

Tools

MS Word

Excel

Adobe Acrobat

Job description

iRhythm Technologies, Inc. is seeking a Quality Assurance/Complaints Specialist in Iloilo.

The role focuses on evaluating complaints for regulatory reporting, coordinating investigations with cross-functional teams, and maintaining thorough records to support ISO 13485 and FDA/EU compliance. The ideal candidate has 3–5 years in QA or complaint processing in medical devices, strong problem-solving, and solid technical writing abilities.