Abbott Rapid Diagnostics (ARDx) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

This position is located in Manila and may support products within the Abbott Rapid Diagnostics business. In this role you will be responsible for managing and maintaining regulatory compliance programs, as well as providing support as needed to other quality assurance functions. This position is expected to provide problem solving skills and critical thinking for investigation and troubleshooting activities.

Essential Duties and Responsibilities

• 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.

• Perform other duties and projects as assigned.

• Perform customer complaint investigation activities, including deciding which complaints will be investigated, how they will be investigated, coordinating data generating activities, evaluating data and writing investigation summaries /conclusions. Maintain effective communication with Intake Hubs (worldwide locations) regarding product complaint investigations. Review of complaint cases at earliest stage to assess Technical Service performance. May perform site visits as needed to assess kit performance, including specific activities for Amplicon remediation. Support revision of Standard Operating Procedures, guidance documents, and training materials as needed.

Basic Qualifications – Education / Experience / Skills

• Bachelor’s Degree in Biology, Chemistry, or Life Sciences, and / or other related technical field or the equivalent education and experience.

• Proficiency in database software, internet-based software and word processing software.

• Proficiency in spreadsheet software

• Proficiency in database software, internet-based software and word processing software.

Preferred Qualifications

• 5+ years of experience in Quality Assurance role in the medical device industry

• 2+ years of experience in QA/QC role in medical device or biotech industry

Competencies

• Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements.

• Demonstrated ability to manage complex programs, and multiple priorities in a timely manner.

• Demonstrated ability to analyze data and make appropriate conclusions.

• Ability to work well in dynamic work environment with changing priorities.

• Ability to work independently and collaboratively.