Product Quality Assurance Analyst - Complaints & CAPA Specialist

Thornton Tomasetti; Taguig; On-site; PHP 480,000 - 720,000; Full time

Job summary

Abbott Philippines seeks a Product Quality Assurance Analyst to support the Cardiometabolic and Informatics unit in Manila. You will review complaints, analyze data, and coordinate with intake sites to close issues per GMP, ISO13485, and FDA standards.

You will work independently and in teams, ensuring compliance and timely follow-up, while maintaining high documentation quality and clear communication with internal and external partners.

Qualifications

• Bachelor’s degree in natural sciences or equivalent technical discipline with 2–5 years relevant experience, or Master’s degree with 1–3 years relevant experience.

Responsibilities

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to quality processes per ISO, FDA, and other regulatory agencies.
• Review, evaluate, investigate and close complaints, incl. escape potential reportable events.
• Respond to inquiries regarding products from customers and employees.
• Attend meetings with intake sites, perform product follow-up.
• Perform data analysis to identify product/market trends for CAPA investigations.
• Prepare procedures ensuring GMP/ISO13485 compliance.
• Perform product-specific troubleshooting training as needed.
• Other duties as assigned.

Skills

English communication

Initiative

Analytical thinking

Precision

Documentation

Education

Bachelor’s degree in natural sciences or equivalent

Master’s degree in natural sciences or equivalent

Job description

Abbott Philippines seeks a Product Quality Assurance Analyst to support the Cardiometabolic and Informatics unit in Manila. You will review complaints, analyze data, and coordinate with intake sites to close issues per GMP, ISO13485, and FDA standards.

You will work independently and in teams, ensuring compliance and timely follow-up, while maintaining high documentation quality and clear communication with internal and external partners.