Medical Device Complaint & Quality Investigator

IRhythm Technologies Inc.; Manila; Presencial; PHP 3.774.000 - 5.031.000; Jornada completa

Descripción de la vacante

iRhythm is seeking a Quality Assurance professional to evaluate complaints for regulatory reporting and to coordinate investigations in a cross-functional environment. You will ensure accurate analytical conclusions and support continuous process improvements.

The role requires a science/tech background, 3–5 years in QA or complaint handling, and familiarity with ISO 13485 and FDA/EU standards. Office-based with potential hybrid onboarding was mentioned.

Formación

• Bachelor’s Degree or Associate Degree in science, technology, or medical fields
• 3-5 years of experience in Quality Assurance or complaint processing
• Knowledge of ISO 13485, FDA 21 CFR 820, EU MDD/MDR is a plus
• Strong problem-solving and analytical skills
• Excellent written and verbal communication

Responsabilidades

• Evaluates complaints to determine reportability per 21 CFR Part 803 and related regulations
• Performs and coordinates complaint investigations with cross-functional teams
• Analyze information from a technical perspective and document conclusions
• Maintain complaints log and participate in process improvements
• Work across teams and support CAPA/non-conformances as needed

Descripción del empleo

iRhythm is seeking a Quality Assurance professional to evaluate complaints for regulatory reporting and to coordinate investigations in a cross-functional environment. You will ensure accurate analytical conclusions and support continuous process improvements.

The role requires a science/tech background, 3–5 years in QA or complaint handling, and familiarity with ISO 13485 and FDA/EU standards. Office-based with potential hybrid onboarding was mentioned.