Lead, QA

ICU Medical•Southington, CT

2d•Onsite

About The Position

The Quality Inspector Lead is designed to lead and coordinate the activities of 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.

Requirements

High School diploma or GED equivalent
Minimum of 3 years in a Quality Assurance or development role
Must be 18 years of age

Nice To Haves

Previous QA Lead experience preferred.
Experience with ASTM Standards
Experience with ISO 9001 and medical manufacturing environments
cGMP knowledge
Strong knowledge of Plastic Processing
Familiarity with ASTM Standards a plus
Familiarity with ISO 9001 and Medical Manufacturing Environments a plus

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
Provide other job-related duties as assigned