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Quality Assurance Lead

2 months ago

Salt Lake, Utah, United States ICU Medical Full time
Job Title: Quality Assurance Lead

ICU Medical is seeking a highly skilled Quality Assurance Lead to join our team. As a Quality Assurance Lead, you will be responsible for leading and coordinating the activities of non-exempt personnel, overseeing inspections, testing of sub-assemblies/final product, and controlling products that are on hold or that have been dispositioned.

Key Responsibilities:
  • Proficient in reading, interpreting, and understanding drawings and specifications
  • Assigning work to QA inspectors as required
  • Ability to make decisions regarding product and involving engineering when needed
  • Report and generate material non-conformance lot reports (NLR's)
  • Communicate quality issues with Production Engineering, Planning, and other departments as necessary within the organization
  • Strong problem-solving ability
  • Train employees in Quality assurance procedures and assist management team in developing new cost improvement programs
  • Follow cGMP
  • Excellent organization skills
  • Proficient at basic computer skills
Requirements:
  • Strong knowledge of Plastic Processing
  • cGMP knowledge
  • Basic math skills
  • Basic computer knowledge
  • Strong written and verbal communication skills
  • Familiarity with ASTM Standards a plus
  • Familiarity with ISO 9001 and Medical Manufacturing Environments a plus
Education and Experience:
  • High School diploma or GED equivalent
  • Minimum of 3 years in a Quality Assurance or development role
  • Previous QA Lead experience preferred
  • Experience with ASTM Standards
  • Experience with ISO 9001 and medical manufacturing environments

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.