Quality Assurance Supervisor

hace 2 semanas


Tijuana, Baja California, México Cardinal Health A tiempo completo

Job Summary

We are seeking a highly skilled Quality Assurance Supervisor to join our team at Cardinal Health. As a Quality Assurance Supervisor, you will be responsible for managing product and service quality planning, evaluation, and control. You will work cross-functionally with various teams to develop and implement prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.

Main Responsibilities

  • Act as regulatory expert for functional teams in the execution of change management and validations activities for products, processes, materials, and software.
  • Support and guide QA Engineering activities related to projects that impact the facility, product, and manufacturing operation.
  • Lead the Risk Management Process for the manufacturing site and products under responsibility.
  • Support and guide the team in product and process investigations arising from manufacturing, processes, facilities, suppliers, materials, complaints, and nonconformities of audits and inspections.
  • Directly responsible for handling non-conforming product and the entire process to be followed for adequate disposal and retention based on applicable procedures and regulations.
  • Support and direction in transfer projects and new products to ensure compliance and effectiveness during execution.
  • Assess trends in products and processes to activate corrective and preventive actions when applicable.
  • Develop plans as part of continuous improvement.
  • Ensure all processes and procedures developed and under responsibility comply with the quality system, corporate policies, regulations, and any other applicable requirements.
  • Ensure projects are completed on time and within budget.
  • Assist the quality research and development team in ensuring proper implementations in applicable processes and products.
  • Assist the Site Quality Manager with Product Corporate Holds and all activities and information required for distributed product analysis.
  • Development and management of quality engineers to ensure compliance with activities, their knowledge, and growth.
  • Lead continuous improvement projects of the department focused on the quality of the product, patient, efficiency, and cost.

Qualifications

  • Bachelor's degree in an Engineering field or similar.
  • 4+ years of supervisory experience, leadership, and mentorship of fellow engineers.
  • 3+ years of medical device manufacturing experience is highly desired.
  • Advanced English.
  • Demonstrate experience in ISO13485, FDA QSR, and all applicable regulations for MDSAP.
  • ISO Risk management.
  • Solid understanding and experience in the areas of Process Validation.
  • Computer knowledge in Excel, Word, PowerPoint, Minitab, or others.

What is Expected of You and Others at This Level

  • Coordinates and supervises the daily activities of operations or business support staff.
  • Administers and executes policies and procedures.
  • Ensures employees operate within guidelines.
  • Decisions have a direct impact on work unit operations and customers.
  • Frequently interacts with subordinates, customers, and peer groups at various management levels.
  • Interactions normally involve information exchange and basic problem resolution.


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