Quality Inspector I

ICU Medical; Salt Lake City (UT); On-site; USD 44,000 - 76,000; Full time

Job summary

An established industry player is seeking a Quality Inspector I to join their team. This entry-level position is vital for ensuring that medical products meet stringent internal and external specifications. The role involves performing a variety of inspections using tools such as microscopes, calipers, and micrometers. The ideal candidate will have a keen eye for detail and a commitment to quality, contributing to the overall success of the company in delivering clinically essential products. If you are eager to start your career in quality assurance within the medical equipment manufacturing sector, this opportunity is perfect for you.

Qualifications

• Entry-level inspection of medical products ensuring compliance.
• Ability to perform inspections using various tools like microscopes.

Responsibilities

• Conduct mechanical and visual inspections of materials and components.
• Maintain compliance with Quality System Regulations and cGMP.

Skills

Visual Inspection

Basic Functional Testing

Communication Skills

Education

High School Diploma or GED

Technical Degree

Tools

Microscopes

Calipers

Micrometers

Agile Document Management

Job description

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Position Summary

Able to perform entry level inspection, repetitive tasks associated with visual inspections and basic functional testing knowledge. Responsible for ensuring company products are in compliance with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. Ability to perform inspection tasks use microscopes, calipers, and micrometers. Able to complete 10-15 different inspection.

• Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements
• Perform PCI activities for NA Notifications at the US Regional Service Center as needed.
• Follows all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e cGMP compliance).
• Supports the paper document archival process including preparation of pallets for shipment to R4 as well as the scanning of Documents for electronic archival in Agile.
• Initiate Non-Conformance reports as required
• Supports NC and CAPA activities as needed
• Work on special projects as they may arise
  
  

Job Description

Job Title

Inspector I, Quality

FLSA Status

Non-Exempt

Position Summary

Able to perform entry level inspection, repetitive tasks associated with visual inspections and basic functional testing knowledge. Responsible for ensuring company products are in compliance with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. Ability to perform inspection tasks use microscopes, calipers, and micrometers. Able to complete 10-15 different inspection.

Essential Duties & Responsibilities

• Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements
• Perform PCI activities for NA Notifications at the US Regional Service Center as needed.
• Follows all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e cGMP compliance).
• Supports the paper document archival process including preparation of pallets for shipment to R4 as well as the scanning of Documents for electronic archival in Agile.
• Initiate Non-Conformance reports as required
• Supports NC and CAPA activities as needed
• Work on special projects as they may arise
  
  

Knowledge, Skills & Qualifications

• Minimum HS graduate or GED equivalent. AA or Technical Degree preferred.
• Must have basic computer skills to regularly access and document information in a computer.
• Must have basic written and oral communication skills adequate to communicate with other team members, understand verbal instructions, and read and comprehend written work instructions including words and engineering drawings.
• Demonstrated knowledge with medical device regulations and FDA regulatory standards preferred.
  
  

Minimum Qualifications

• Must be at least 18 years of age
  
  

Travel Requirements

• Typically requires travel less than 5% of the time
  
  

Physical Requirements And Work Environment

• Must be able to perform essential job functions in an office environment.
• Long periods of sitting to enter/ analyze data is expected
• Must have adequate manual dexterity to operate standard office equipment
• Must be able to occasionally lift objects up to 25 lbs.
  
  

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. 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.
  
  

ICU Medical EEO Statement

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

• “Know Your Rights” Poster
• Pay Transparency Nondiscrimination Provision
  
  

ICU Medical CCPA Notice to Job Applicants

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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