Product Quality Assurance Analyst

Thornton Tomasetti; Taguig; Presencial; PHP 480.000 - 720.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

English communication

Initiative

Analytical thinking

Precision

Documentation

Educación

Bachelor’s degree in natural sciences or equivalent

Master’s degree in natural sciences or equivalent

Descripción del empleo

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. escape 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.

Authority

The framework for the position is given by the regulatory requirements applicable to the IVD industry as defined in Quality Manual, Procedural Works, and plans established by the Quality Leadership Team in CMI BU. The job holder prioritizes his / her daily work independently within given time limits and deadlines. If necessary, clarify priorities with the next in line manager, or project manager if the tasks are project-related. The position holder has decision-making authority for the responsibilities given in paragraph 1 and approved project plans.

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
• Precise and systematic
• Good documentation skills

Compensation

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

Job Family, Division, Location, and Work Details

• 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)

About Abbott

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.

Equal Opportunity Statement

Abbott welcomes and encourages diversity in our workforce.

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