Product Quality Assurance Analyst

Abbott Laboratories; Hinoba-an; On-site; PHP 350,000 - 550,000; Full time

Job summary

Abbott Laboratories in Manila, Philippines is seeking a Product Quality Assurance Analyst within the Cardiometabolic and Informatics unit. The role focuses on analyzing complaints, following established procedures, and ensuring compliance with GMP, ISO13485, and regulatory standards.

You will collaborate with intake sites and cross-functional teams to resolve issues and support CAPA investigations. The position emphasizes independent work and teamwork, with strong English communication and

Qualifications

• Bachelor’s degree in natural sciences or equivalent with 2–5 years' experience, or Master’s degree with 1–3 years' experience
• Internal experience can substitute education with 5 years in related fields
• Experience in complaint administration preferred
• Knowledge of GMP/ISO13485 requirements in QA environments
• Knowledge of diagnostics products’ technology and performance

Responsibilities

• Carry out duties in compliance with policies and procedures
• Ensure quality processes align with ISO, FDA, and regulatory standards
• Review, evaluate, investigate and close complaints; escalate reportable events as needed
• Respond to inquiries about CMI BU products from customers and staff
• Attend intake site meetings and perform product follow-up
• Perform data analysis to identify product and market trends for CAPA investigations
• Prepare procedures to ensure GMP/ISO13485 compliance of systems and documentation
• Provide product troubleshooting training as needed
• Carry out other duties as assigned

Skills

English communication

Documentation skills

Analytical thinking

Independence

Initiative

Education

Bachelor’s degree in natural sciences or equivalent technical discipline

Master’s degree in natural sciences or equivalent technical discipline

Job description

JOB DESCRIPTION: The position of Product Quality Assurance Analyst is within our Cardiometabolic and Informatics Business Unit located in Manila, Philippines. This role will have frontline communications with established intake sites. Key attributes of this position include the ability to quickly and accurately ascertain all available information associated with complaints. Additionally, individuals in this position will be required to conduct analysis and follow up activities associated with these complaints. Finally, individuals in this position need to be able to work independently and in team environments in order to ensure complaints are analyzed and closed in accordance with established procedures.

Responsibilities and Duties

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Main responsibility is review, evaluate, investigate and close complaints, incl. elevate potential reportable events for evaluation of reportability
• Respond to inquiries regarding CMI BU products from customers and employees in other parts of the company
• Attend meetings with the intake sites departments, incl. perform active product follow-up with them
• Perform customer data analysis to identify product and market related trends as part of requested complaint searches, e.g. as part of CAPA investigations
• Prepare procedures that ensure good work processes in the department and that systems and documentation meet the requirements of GMP, ISO13485, and other relevant standards and regulatory requirements
• Perform product specific troubleshooting training as needed
• Responsibility for specific tasks will be reflected in the employee’s training plan
• Perform other duties and projects as assigned.

Minimum Qualifications / Education / Experience

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

Preferred Qualifications

• Experience in complaint administration
• Experience from work with quality assurance, production and/or quality control according to GMP / ISO 13485 requirements
• Knowledge of diagnostics products’ technology, applications and expected performance

Personal Characteristics

• Excellent communication skills in English; in writing, reading and speaking
• Good ability to take initiative and work independently
• Good ability to analyze, and understand the customers’ needs
• Good documentation skills
• Precise and systematic

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: CMI ARDx Cardiometabolic and Informatics

LOCATION: Philippines > Taguig City : Five/Neo Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.