About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. The Senior Analyst, Product Quality Assurance (PQA) has various objective/functions related to post market product handling, data analysis, product quality improvements and periodic risk reviews. The scope of activities includes investigation relationship of complaints/adverse events to product quality or manufacturing processes and driving activities within internal procedures for continuous product quality improvement. Lead regular product complaint data and signal detection data meeting with technical analysis. Initiate activities with cross-functional team to drive continuous product quality improvement. Lead monthly product return data and failure analysis meeting. Monitor any open action items from quality management activities related to post market activities. Lead product periodic risk management review and update risk management reports as needed. Evaluate Risk management data for compliance with procedures and approve risk management files. Maintain compliance to global regulatory requirements for complaint registration, investigation and provides feedback into product quality improvement initiatives. Interface with regulatory agencies involving post marketing field related problems and product inquiries and during routine site/process inspection. Handle product quality issues with warehouse/distributors/commercial QAs to ensure customer satisfaction. Qualifications Bachelor’s degree in Science, Engineering or equivalent + 6 years experience OR Master’s degree with 4 years experience Knowledge of medical device quality management system and regulations Ability to interact with cross functional teams Strong presentation skills and communication skills Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.