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Senior Quality Assurance Engineer

hace 2 meses

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

Abbott Laboratories is a leading global healthcare company that develops innovative medical technologies to improve people's lives.

We're committed to advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Opportunity

This position works closely with our Manufacturing and Engineering teams to ensure compliance with quality system requirements and achievement of Key Performance Indicators.

The Senior Quality Assurance Engineer will own and lead process/product validation activities, work closely with Research and Development and Regulatory Affairs personnel to obtain support on sustaining activities and during new product introduction.

Responsibilities include:

  • Verifying company adherence to established Quality System and GMP/ISO standards
  • Completing risk management and risk analysis, including FMEA
  • Working with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis
  • Supporting technical and statistical investigations concerning optimization and compliance to specification
  • Owner of measuring process capability, process controls, and process validation/efforts
  • Working with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
  • Conducting and owning 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 and owning Build At Risk (BAR) Authorizations & Closures
  • Owner, completing, and approving 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, creating, and authoring master validation plans and reports
  • Supporting activities during preparation and execution of audits (External/Internal), functioning as SME for specific Quality activities
  • Owner of 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 presenting on management meetings such as QDR, KPIs, and Management Review
Required Qualifications

STEM (Science, Technology, Engineering, Math) degree (with equivalent experience in medical devices or pharmaceutical quality control)

Bachelor's Degree (University Level)

5-7 years of experience in Quality Engineering positions

At least 5 years of experience