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Santiago de Querétaro

    Quality Engineer - Querétaro, México - Abbott

    Abbott
    Abbott Querétaro, México

    hace 2 semanas

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    Descripción

    The Opportunity

    This position works out of our Queretaro site in Mexico in EP Division. In Abbott's Electrophysiology (EP) business, we're 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.

    Works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR's, MA's, Yield, Cost Reduction projects, etc.) and support/lead process/product validation activities.

    Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements.

    Owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal)

    Responsible for support and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support, validations and Quality Metrics.

    Works with minimum supervision and assignments are broad in nature. Employee uses knowledge to propose alternatives tasks and to bring projects to completion.

    What You'll Do

  • Verify company's adherence to the established Quality System and GMP/ISO standards.
  • Provide support and coaching to lower-level engineering positions and guidance to other areas of the organization on Quality related topics
  • 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.
  • Conducts 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.
  • Own NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
  • Works closely with Sr quality position on completing and documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
  • Leading Build At Risk (BAR) Authorizations, approvals& Closures
  • Own, complete or approve of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
  • Creation and maintenance of Quality Plans and Reports. Also, provide support to lower level engineering positions.
  • Own, execute, review or approve of IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, and mentorship from higher level engineering.
  • Conducting Advanced Statistical Data Analyses using Minitab.
  • Authoring Master Validation Plans and Reports / Quality Plans and Reports.
  • Supports activities during preparation and execution of audits (External / Internal), functioning as SME backup for specific Quality activities.
  • Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support, coach, and mentor non-exempt and entry level exempt personnel.
  • Creating and Communicating details and information of events related to quality to upper management.
  • Participation as listener 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, if required.

    • Required Qualifications

  • Education .- Bachelor Degree (University Level) in STEM (Science, Technology, Engineering (preferred), (experience in medical devices or pharmaceutical quality control preferred)

    • Experience

  • 4-6 years' experience in Quality or Engineering positions.
  • At least 4 years of experience in Quality or Manufacturing Engineering positions.
  • Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
  • Knowledge of statistical/data analysis and report writing experience.
  • Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
  • Experience working on FDA, GMP, and ISO 13485 Regulated environments.
  • Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
  • Project management experience, participating or leading multi-departmental project teams.

    • Language Proficiency

  • Advance Commands of English / Required
    Fluent oral and writing communication including technical writing.

    • Preferred Qualifications & Education

  • ISO 13485 certification as Lead Auditor or similar
  • Experience with SAP.
  • ASQ CQE / Six Sigma certification or similar.
  • Participation or leading multi-departmental project teams.
  • Experience in supervision role.
  • Available to travel long period for training
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