Senior Quality Assurance Engineer

hace 2 días

Ciudad de México, Ciudad de México Abbott Laboratories A tiempo completo
About the Role

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Abbott Laboratories. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and compliance of our medical devices and pharmaceutical products.

Your primary focus will be on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators. You will also be responsible for owning and leading process/product validation activities, working closely with Manufacturing and Engineering teams.

In addition, you will work with Research and Development and Regulatory Affairs personnel to obtain support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements.

You will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support.

Key Responsibilities

  • Verify company's adherence to the established Quality System and GMP/ISO standards.
  • Completion of risk management and risk analysis including FMEA.
  • Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.
  • Supports technical and statistical investigations concerning optimization and compliance to specification.
  • Owner of measuring process capability, process controls, and process validation / efforts.
  • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
  • Conducting & Own NCMR Investigations, CAPAs, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process, Field Actions.
  • Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
  • Leading & Own Build At Risk (BAR) Authorizations & Closures.
  • Own, complete Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
  • Creation and maintenance of Quality Plans and Reports.
  • Owning, Executing, and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications.
  • Conducting Advanced Statistical Data Analyses using Minitab.
  • Owning, create and authoring Master Validation Plans and Reports.
  • Supports activities during preparation and execution of audits (External / Internal), functioning as SME for specific Quality activities.
  • Own Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.).
  • Lead, coach, and mentor non-exempt and entry level exempt personnel.
  • Creating and communicating in a timely manner details and information of events related to quality to upper management.
  • Leading and presenter on management meeting such as QDR, KPIs and Management Review.
  • Perform other duties and responsibilities as assigned by senior management.
  • Perform supervisor activities to Quality Technicians or Quality Engineers, if required.

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