Product Quality Assurance Analyst — Complaints & CAPA

Abbott Laboratories; Philippines; On-site; PHP 300,000 - 600,000; Full time

Job summary

Abbott Laboratories in Manila, Philippines is seeking a Product Quality Assurance Analyst within the Cardiometabolic and Informatics Business Unit. The role involves frontline communication with intake sites and analysis of complaints to ensure closure per GMP and ISO13485 standards.

The candidate will review, investigate, and close complaints, conduct data analysis to identify trends, and participate in CAPA investigations while maintaining compliance with regulatory requirements.

Qualifications

• Bachelor’s degree in natural sciences or equivalent technical discipline with 2–5 years of relevant experience; Master’s degree with 1–3 years of relevant experience.
• Lack of appropriate education level can be replaced or supplemented by 5 years of internal experience in related fields.

Responsibilities

• Review, evaluate, investigate and close complaints; accelerate potential reportable events for evaluation of reportability.
• Respond to inquiries regarding CMI BU products from customers and employees.
• Attend meetings with intake sites departments; perform active product follow-up.
• Perform customer data analysis to identify product and market related trends as part of requested complaint searches (e.g., CAPA investigations).
• Prepare procedures to ensure good work processes and that systems/documentation meet GMP, ISO13485 and other standards.
• Perform product specific troubleshooting training as needed.
• Responsibilities reflected in the training plan; perform other duties and projects as assigned.

Skills

English communication

Initiative

Analytical ability

Documentation skills

Attention to detail

Education

Bachelor’s degree in natural sciences

Master’s degree in natural sciences

Job description

Abbott Laboratories in Manila, Philippines is seeking a Product Quality Assurance Analyst within the Cardiometabolic and Informatics Business Unit. The role involves frontline communication with intake sites and analysis of complaints to ensure closure per GMP and ISO13485 standards.

The candidate will review, investigate, and close complaints, conduct data analysis to identify trends, and participate in CAPA investigations while maintaining compliance with regulatory requirements.