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Lead, QAICU Medical • Southington, Connecticut, United States
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Lead, QA

ICU Medical
  • US
    Southington, Connecticut, United States
  • US
    Southington, Connecticut, United States
Apply Now

About

Job Description The Quality Inspector Lead is designed to lead and coordinate the activities of the non‑exempt personnel. The individual will oversee inspections, testing of sub‑assemblies/final product, and control products that are on hold or that have been dispositioned. The individual supports manufacturing operations and engineering in the objective of producing a quality product in a timely, efficient and economical manner. The individual will need to demonstrate proficiency in and knowledge of statistical sampling techniques, measurement and functional test equipment, and medical device GMP regulations. This job requires the lead to write, implement and enforce standard operating procedures and safety rules.
Essential Duties & Responsibilities
Proficient in reading, interpreting, and understanding drawings and specifications
Assigning work to QA inspectors as required
Ability to make decisions regarding product and involve 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
Provide other job‑related duties as assigned
Knowledge, Skills & Qualifications
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
Must be detail oriented and follow instructions and specifications meticulously
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
cGMP knowledge
Minimum Qualifications
Must be 18 years of age
Travel Requirements
Typically requires travel less than 5% of the time
Physical Requirements And Work Environment
Work is performed in a clean room environment
Employee may be required to sit or stand for long periods of time, depending on machine operated
Operator is required to use computer or touch screen to enter work order data
Must be able to occasionally move and lift objects up to 30 lbs
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  • Southington, Connecticut, United States

Languages

  • English
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