Test Control Procedure (TCP) Specialist

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Create, analyze, and process electronic Quality testing documents in compliance with QSR, ISO13485, and other applicable standards.
• Initiate Document Change Requests and associated packages relating to electronic documents and verify for correctness of the submitted Change in alignment with testing site requirements.
• Participate in project teams to further develop efficient and effective electronic Quality testing and ancillary documents.
• Create, analyze, and process electronic Quality testing and ancillary documents for new product development and on-market updates.
• Assist in resolving complex issues, provide judgment and recommendations to the manager.
• Assist in defining and documenting departmental procedures and standards to meet Regulatory and Division requirements.
• Provide customers (internal) with technical assistance in the development and execution of the electronic Quality testing document.
• Build and maintain successful cross-functional relationships with internal departments such as R&D, Manufacturing, Quality Control, Regulatory Affairs, and Operations.
• Be able to work with a diverse and dynamic international team providing support for multiple sites.
• Perform and support data mining activities.

Required Qualifications

• Bachelor's Degree or an equivalent combination of education and work experience.  
• 2-5 years of related work experience with a good understanding of specified functional area.
• Working knowledge and application of business concepts, procedures and practices.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.

Preferred

• Experience on LIMS system and capable for authoring test procedures in LIMS and understanding the process.
• Experience with IBM Cognos and/or Microsoft Power BI is a plus
• Knowledge of regulations and standards affecting IVDs and medical devices, e.g. ISO13485
• Excellent written, verbal and interpersonal communication skills
• Works effectively with others while providing high level customer service

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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