Quality Engineering Manager

hace 4 semanas


Tijuana, Baja California, México Cardinal Health A tiempo completo

Job Overview


The Senior Engineer Quality leads quality assurance processes at Cardinal Health. This role is responsible for diligent and thorough analysis, investigation of product complaints and leads process improvement activities for complaint investigations.



About the Role


This position is estimated to pay $80,000 - $110,000 per year based on experience and qualifications in the medical device industry.



Responsibilities

  • 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


Requirements

  • 2-4 years QA complaint handling experience in medical device
  • Bachelor's degree in 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


About You


We are looking for candidates who can apply their working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks. If you have experience in quality engineering and are passionate about delivering high-quality products and services, we encourage you to apply.



Why Choose Us?


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.



Equal Employment Opportunity


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.



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