Quality Inspector I-Weekend 4th Shift

ICU Medical; Southington (CT); On-site; USD 40,000 - 100,000; Full time

Job summary

ICU Medical is seeking a Quality Inspector I for a weekend shift. The role involves conducting mechanical and visual inspections of materials and components. Candidates should possess a high school diploma and be skilled in using inspection tools. Knowledge of medical regulations is a plus, and the work environment requires manual dexterity and attention to detail.

Qualifications

• High School diploma or GED required; Technical degree preferred.
• Demonstrated ability with inspection tools such as calipers and micrometers.
• Knowledge of FDA regulations preferred.

Responsibilities

• Perform mechanical and visual inspections per specification requirements.
• Maintain compliance with applicable Quality System Regulations.
• Support document archival processes and initiate Non-Conformance reports.

Skills

Basic computer skills

Basic written and oral communication skills

Ability to perform inspection tasks

Knowledge of medical device regulations

Education

High School graduate or GED equivalent

AA or Technical Degree preferred

Job description

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

Job Description

Essential Duties & Responsibilities

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

Knowledge And Skills

• Basic computer skills in order to regularly access and document information.
• 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.
• Ability to perform inspection tasks using microscopes, calipers and micrometers. Ability to complete 10-15 inspections.
• Demonstrated knowledge of medical device regulations and FDA regulatory standards preferred.
  
  

Minimum Qualifications, Education And Experience

• High School graduate or GED equivalent. AA or Technical Degree preferred.
• Must be 18 years of age.
  
  

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.
• Typically requires travel less than 5% of the time.
  
  

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 being an 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, 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

Know Your Rights: Workplace Discrimination is Illegal Poster

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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