Quality Assurance Specialist

7 days ago


Athens, Georgia, United States Quidel Corporation Full time
About the Role:

The Quality Engineer is a crucial member of our team, responsible for ensuring the highest standards of quality in our manufacturing process. We are seeking an experienced Quality Engineer to join our team in Athens, Ohio, and contribute to the success of QuidelOrtho.

  • Partner with operations to evaluate and address quality events, including nonconformances, product dispositions, and customer complaints.
  • Analyze and monitor key quality metrics, developing action plans to address unfavorable trends.
  • Promote continuous improvement activities, seeking out opportunities to optimize processes and systems.
  • Support product and process root cause investigations, collaborating with product support, engineering, and operations.
  • Support inspection readiness activities, applying working knowledge of ISO13485 and 21CFR Part 820 regulations.
  • Conduct product risk assessments and manage Product Risk Files.
  • Support change control process, collaborating with R&D on design transfer activities.

Requirements:

  • B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline.
  • Advanced Microsoft Office and statistical software tools, such as MiniTab.
  • Experience with establishing sample plans, quality test plans, and summarizing/reporting data analysis.
  • Excellent communication and documentation skills.
  • Ability to work effectively independently and as part of a cross-functional team.


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