Senior Quality Assurance Specialist

hace 3 semanas

Tijuana, Baja California, México Cardinal Health A tiempo completo
Job Summary

The Senior Engineer Quality leads quality assurance processes at the assigned facility. This role involves diligent and thorough analysis, investigation of product complaints and leads process improvement activities for complaint investigations.

About the Role
  • Perform device analysis in accordance with model-specific procedures and protocols.
  • Provide statistical support and analytical problem-solving to identify root cause of problems.
  • Responds to complaints and non-compliance and signs off on deviations, validation, and other design verification protocols.
  • 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 supports external audits.
  • Performs other duties in line with business needs.
What We Offer

We are offering a competitive salary range of $110,000 - $140,000 per year, depending on experience, plus benefits, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

Requirements
  • 2-4 years 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 regulation and standards.
  • Advance fluency in English.
  • Demonstrated ability to work effectively with cross-functional teams for complaint investigation and root cause analysis.
  • Thorough knowledge of relevant GMP's and Good Documentation Practices.
  • Strong analytical skills.
  • Proficient in Microsoft Office tools such as Word, Excel, PowerPoint, Outlook.
  • Proficiency in Minitab.
  • Ability to thrive in a dynamic environment.
Why Work With Us

CARDINAL HEALTH is committed to creating a diverse and inclusive workplace that values differences and promotes equal opportunities for all employees. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.

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