Technician QA III Post Market Laboratory DAL

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 nonstandard 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 nondestructive 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 EHSrelated initiatives.

Qualifications :

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).

Additional Information :

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 AbbVies 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.

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Work :

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