Quality Assurance Specialist

8 hours ago


Elkton, Minnesota, United States Terumo Full time
Job Summary

The Quality Engineer II position plays a crucial role in ensuring that goods meet or exceed customer expectations and requirements. This role will work closely with the Operations and Engineering Team to drive continuous improvement and support production and project activities.

Key Responsibilities
  • Investigate and implement best-in-class Quality Engineering practices.
  • Provide quality engineering support and coordinate the execution of assigned development project activities.
  • Establish effective corrective action plans and lead the implementation of quality assurance plans, process controls, and CAPA systems.
  • Act as a project lead or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Identify non-conformance trends and develop technical investigation plans.
  • Perform data analysis and execute experiments to qualify or resolve product and process issues.
  • Develop and implement master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures.
  • Provide training and support for quality system processes and quality engineering practices.
Requirements
  • Bachelor's degree in engineering, engineering technology, computer science, mathematics, or physics.
  • At least three years of experience in a medical device or highly regulated industry.
  • Experience working in a manufacturing environment is preferred.
  • Certification as a CQA, CQE, or CQM and membership in the ASQ is preferred.
Working Conditions/Physical Requirements

The Quality Engineer II will work in a collaborative and respectful team environment, with a focus on achieving more than expected. The ideal candidate will be self-motivated, detail-oriented, and able to work effectively in a fast-paced environment.

Terumo is an equal opportunity employer and welcomes applications from diverse candidates. We value diversity of background and opinion and prohibit discrimination or harassment on the basis of any legally protected class.



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