Hybrid Engineer II, Design Quality

Posted last week

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About the role

  • Quality Engineer providing support for ICU Medical development through CAPA investigations and ensuring compliance with quality standards. Engage in design reviews and risk assessments in a professional office environment.

Responsibilities

  • Provide quality support for ICU Medical Hardware and Consumable development.
  • Support activities such as CAPA investigations, design projects, and ensure compliance with quality system requirements.
  • Utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc.
  • Assure conformance with regulations of the FDA and other international regulatory agencies.
  • Ensure all Quality attributes for design changes are met.
  • Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, and design transfers.
  • Evaluate, prioritize, and mitigate potential product and process risks to improve quality.
  • Support internal and/or external audits and inspections.
  • Effectively interact with cross-functional team members.
  • Provide quality support for on-market product issues, bringing issues to closure.

Requirements

  • Must be at least 18 years of age
  • Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
  • Minimum of 2 - 4 years of experience in R&D and/or Quality is required.
  • ASQ CQE certification preferred or ability to obtain within one year.

Benefits

  • Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
  • A wide range of benefit options at affordable rates
  • Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement

Job title

Engineer II, Design Quality

Job type

Experience level

JuniorMid level

Salary

$71,250 - $102,125 per year

Degree requirement

Bachelor's Degree

Location requirements

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