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Abbott Operations QA Project Manager in Irving, Texas

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Position Overview:

  • This role will drive Operations Quality Assurance process initiatives driven through strategic planning and in-depth data analytics that ensures compliance with customer requirements, regulatory agencies, government regulations and engineering specifications while instilling site accountability for governance of the Quality System. The Operations Quality Specialist provides solutions to a wide range of difficult problems, and ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.

Primary Job Scope:

  • Collaborates with Manufacturing, Engineering, Purchasing, Supply Chain, Incoming Quality, Equipment Calibration, to understand team priorities and optimize communications for maximal productivity in a fast-paced environment. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Understands material movement, non-conforming material controls, and potential shortages that impact production in a regulated environment in order to optimize process performance.

  • Uses transactional knowledge and strategic ingenuity to develop process improvements and new business tactics and applies knowledge of Enterprise Resource Planning (ERP)/ Warehouse Management System (WMS) to bring those process improvements to fruition.

  • Understands incoming inspection techniques and in-house/external calibration standards in order to collaborate with Supplier Quality Engineers and external suppliers to drive improvements.

  • Completes duties within a tightly controlled quality environment that promotes continuous improvement and adherence to published operating procedures.

  • Optimize raw material, sub assembly, equipment, and/or finished goods flow that meet cGMP requirements.

  • Monitors and analyzes operations quality performance indicators in order to proactively identify potential problems. Critically analyzes potential impact of forecast, capacity, and schedule changes with respect to customer (internal and external) needs.

  • Budgets own time to carry out assigned duties that support business goals.

  • Interacts constructively with employees, managers and cross-functional peers. This includes other quality teammates as well as engineering, operations, and upper management.

  • Executes strong Microsoft Excel skills to help with data mining and data analytics in identifying opportunities of operational excellence. Works as a resource to identify process issues and execute implementation of fixes on a time sensitive basis to ensure customer commitments are met. Establishes and collaborates on methods to gather and process raw data into metrics for all Operations QA metrics including: MRB, NCMR, Quality Hold, Product Release, Equipment/IQA capacity & efficiency.

  • As needed, collaborates with operations quality and CAPA teams to strategize, track, and implement corrective and preventative actions plans related to operations quality department.

Qualifications:

  • Apprenticeship or Bachelor’s Degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.

  • At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.

Preferred Qualifications:

  • Preferred experience in the Healthcare industry. Has a history of completing successful projects and driving positive compliance outcomes.

  • Excellent communication (verbal and written) and Microsoft Excel skills.

  • Nonconformance management and resolution (CAPA) experience.

  • Operations Quality experience including equipment, incoming inspection, or quality manufacturing preferred.

  • Experience in Material Controls/Supply Chain Quality including Enterprise Resource Planning (ERP)/ Warehouse Management System (WMS) preferred.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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