Technician, QA III Post Market Laboratory (DAL)

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Perform the analysis of returned medical devices in order to confirm the existence of failure types and document accurate information for future research (if applicable) and product development. The scope includes receipt, disinfection and analysis of returned medical devices, handling and filing of documentation related to the device, as well as recording information in the corresponding systems as appropriate.

MAJOR RESPONSIBILITIES 
• Perform standard and non-standard tasks (observation, analysis and testing), following general instructions and under general supervision, on a returned medical device. Accurately record the information and/or results obtained from the analysis carried out in the corresponding system. Standard and additional tasks may include: Visual inspection for any abnormalities or potential failures such as unidentified breaks or openings and to conduct analysis of different types of medical devices independently.
• Ensure the continuous flow of analyzes of medical devices received in the laboratory to complete the analyzes on the established dates, maintaining expected performance, following established process controls, identifying priorities and completing the corresponding documentation on time.
• Maintain active comunication with external departments such as Post Market Quality Assurance (PMQA) to resolve incongruencies between medical devices received and the complaints system and assist on any request from external departments to process medical devices that require additional analyzes.
• Implement experiments and tests necessary to complete the projects specified by the laboratory engineers or the personnel who request it, as applicable. Analyze and test the returned medical device on characteristics such as dimension, performance and mechanical properties.
• Prepare and perform destructive and non-destructive mechanical tests on materials, parts and the device to measure their performance and mechanical properties. Includes the performance of chemical tests as applicable or required by the laboratory Engineer.
• Recommend modifications to existing quality and production standards. Provide assistance with documentation for Change Control and material and design review.
• Support the investigation of design complaints by conducting analysis of returned product. Analyze and interpret the results of observations, using routine or specific calculations under minimal supervision and review. Support the investigation of deviations from expected results.
• Ability/availability to handle medical devices that have been explanted and/or present biohazard residues.
• Ensure compliance with corporate and legal EHS requirements, through compliance with internal policy and procedures. Likewise, guarantee compliance through the adoption of strategies, internal controls, communication and necessary training.
• Continuously improve EHS results through leadership, commitment and active participation in all EHS-related initiatives.

Bachelor in middle education
Student of Industrial Engineering, Chemistry or related field, with at least 40% of the degree completed or graduate of Quality Technician
At least an B1+  level of English according to the European framework in the English language (able to read and interpret procedures in English, generate summaries of the analyzes carried out and communicate with external personnel).

At least 1 year experience in the medical device industry, manufacturing, quality or experience in the analysis of returned devices (if the experience is not specifically related to returned medical devices, the knowledge acquired will be evaluated).

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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