Senior Quality Assurance Engineer

hace 4 semanas

Tijuana, Baja California, México Cardinal Health A tiempo completo

Quality Assurance at Cardinal Health

Cardinal Health's Quality Assurance team is responsible for ensuring the highest quality products and services. As a Senior Quality Assurance Engineer, you will lead quality assurance processes at our assigned facility, analyzing product complaints and leading process improvement activities.

Responsibilities

  • Perform device analysis in accordance with model-specific procedures and protocols.
  • Provide statistical support and analytical problem-solving to identify root causes of problems.
  • Respond to complaints and non-compliance, signing off on deviations, validation, and other design verification protocols.
  • Conduct trending analysis with non-conformance compliance and develop month-end reports and management reviews.
  • Develop corrective and preventative actions for quality-related processes.
  • Serve as an internal auditor and support external audits.
  • Perform other duties in line with business needs.

Qualifications

  • 2-4 years of QA complaint handling experience in medical devices.
  • Bachelor's degree in a related field or equivalent work experience, preferred.
  • Knowledge of FDA and ISO 13485 regulations and standards.
  • Advanced fluency in English.
  • Demonstrated ability to work effectively with cross-functional teams for complaint investigation and root cause analysis.
  • Thorough knowledge of relevant GMPs and Good Documentation Practices.
  • Strong analytical skills.
  • Proficient in Microsoft Office tools, such as Word, Excel, PowerPoint, and Outlook.
  • Proficiency in Minitab.
  • Ability to thrive in a dynamic environment.

What We Expect

  • Apply working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
  • Work on projects of moderate scope and complexity.
  • Identify possible solutions to a variety of technical problems and take action to resolve.
  • Apply judgment within defined parameters.
  • Receive 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.

To read and review this privacy notice, click here.

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