Position Summary
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 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
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 specification 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
- While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
- Operator is required to use computer or touch screen to enter work order data
Must be able to occasionally move and lift objects of up to 30 lbs
Skills Required
- High School diploma or GED equivalent
- Minimum of 3 years in a Quality Assurance or development role
- Previous QA Lead experience
- cGMP knowledge and ability to follow cGMP
- Experience with ISO 9001 and medical manufacturing environments
- Experience with ASTM Standards
- Strong knowledge of Plastic Processing
- Proficient in reading, interpreting, and understanding drawings and specifications
- Basic math skills
- Basic computer proficiency (data entry, touch screens)
- Strong written and verbal communication skills
- Detail oriented and able to follow instructions and specifications meticulously
- Must be 18 years of age
ICU Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICU Medical and has not been reviewed or approved by ICU Medical.
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Retirement Support — Retirement offerings include a 401(k) with a company match and mentions of immediate vesting in some cases. Feedback suggests this component is one of the more reliable strengths of the package.
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Leave & Time Off Breadth — Paid time off and holidays are consistently highlighted as stronger elements within the benefits mix. Feedback suggests time-off policies compare favorably relative to other benefit areas.
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Healthcare Strength — Core coverage spans medical, dental, and vision alongside HSA/FSA and life/disability options. Feedback suggests the breadth is comprehensive even if the depth feels average in places.
ICU Medical Insights
What We Do
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables. Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients. Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care. For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care. Our focus allows us to bring you: > Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. > The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. > IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. > Significant US IV solutions manufacturing and supply capabilities.
