Senior Quality Assurance Engineer

hace 1 mes

Tijuana, Baja California, México Cardinal Health A tiempo completo

Quality Assurance Role at Cardinal Health

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

Key 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

What We Expect

  • 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.

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