Ingeniero Sr de Calidad

What Quality Engineering contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.

Job Summary

The Senior Engineer Quality Engineer leads quality assurance processes at the assigned facility. This position will be responsible for developing key suppliers to improve their processes and process capability to provide enhanced raw material supply resulting in plant cost reductions through improved raw material quality, reduced waste and inventory reductions.

Responsibilities

  • Leads raw material inspection, in-process monitoring, product testing, and finished goods testing and the applicable lab activities.
  • Responds to complaints and non-compliance and signs off on deviations, validation, and other design verification protocols.
  • Ensures that the on-site lab is testing and escalating issues that arise.
  • Conducts trending analysis with non-conformance compliance and develops month-end reports and management reviews.
  • Develops correctional and preventative actions for quality related processes.
  • Serves as an internal auditor and leads external regulatory auditors throughout the facility.
  • Mentors junior employees.


Qualifications

  • 2-4 years of QA experience in medical device manufacturing
  • Bachelor's degree in related field, or equivalent work experience, preferred
  • English: Advance or Fluent
  • Understanding of ISO13485 and FDA regulations
  • Solid analytical skills


What is expected of you and others at this level

  • Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possible solutions to a variety of technical problems and takes action to resolve
  • Applies judgment within defined parameters
  • Receives general guidance and may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.