Engineer, Quality Assurance CAPA III

About the role

PURPOSE STATEMENT Manage the resolution of exception reports linked to the Quality System (NCRs, PRAs) and audits, providing support in the review and approval of the relevant documentation for the processes mentioned, including problem definitions, investigations, audit responses, action implementation, and others. Ensure compliance with standards (GMPs) and the safety, quality, and finance regulations defined by the company. MAJOR RESPONSIBILITIES Review and approve documents derived from exception reports related to the Quality System in order to document the outcome of the investigation process, including containment, correction, and prevention actions that address the root cause of the finding, as well as the mechanism to verify the effectiveness of the actions implemented. Act as SME in working sessions for quality system events with experts from the areas involved in the finding, in order to develop the investigation and define containment, correction, and prevention actions. Guide the NCR or audit process to ensure that the documentation prepared meets internal and regulatory requirements. Manage and prioritize the available resources for the execution of containment, correction, prevention, and effectiveness verification actions arising from exception reports, in order to ensure timely completion in accordance with the quality system metrics: status updates, extensions, implementation reports, among others. Explain, as a Quality SME, the exception documents requested during external or internal audit processes. Ensure timely compliance with NCR commitments in order to support site quality metric performance. Continuously improve processes and documentation related to the Quality System through process simplification and optimization. Ensure compliance with corporate and legal EHS requirements by adhering to policy and internal procedures. Likewise, ensure compliance through the adoption of strategies, internal controls, communication, and necessary training. Continuously improve EHS results through leadership, commitment, and participation in all EHS-related initiatives. Perform all other duties inherent to the position and those assigned by the immediate supervisor. Bachelor's degree in Engineering Preferred: Electromechanical Engineering, Electrical Engineering, or Chemistry. Intermediate English B2+ (C1 preferred). At least 3 years of experience leading the resolution of CAPAs and NCRs, as well as internal and external audit observations and regulatory agency findings related to the Quality System. At least 1 year of experience in a quality system tied to ISO 13485 medical device regulations. At least 3 years of experience in manufacturing processes in the medical industry. Preferred: ISO 13485 Lead Auditor. Data and Statistical Analytics. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Abbvie? Share your experience