ICU Medical · 19 hours ago
Inspector I
Dublin, OH
Full-time
Onsite
Entry Level
1+ years expICU Medical is a global market leader in IV therapy and critical care products. The Manufacturing Quality Inspector is responsible for monitoring production processes for compliance with cGMP standards and performing quality control checks to ensure product conformity and safety.
Health CareMedical Device
Responsibilities
Inspects materials, batch record documents and final products during the production process or off line (APQR, re-inspection, batch records). Performs and records release functional and dimensional testing. Restarts automated equipment that stopped for quality issues
Evaluates products for defects and recognize unacceptable product. Makes decision regarding product conformity and determines if MQ batch record criteria is met
Performs testing on commodities and final product and determines acceptance according to specifications
Collects file samples, stability testing samples, and laboratory samples in accordance with established procedures
Inputs data (numerical/informational) into batch records, reports and electronic data bases. Recognizes unacceptable product. Monitors production lines for irregularities and reports to area supervisor, accordingly
Works with both internal and external customers. Shares information and provides feedback on material, operational, and mechanical related issues
Performs mathematical calculations such as adding, subtracting, multiplying and dividing and therefore must have working knowledge of mathematical applications
Uses good problem solving and interpersonal skills for effective communications. Follows up on activities to ensure quality is maintained. Assists in area improvements, department changes and meetings
Follows prescribed uniform and gowning requirements. Maintains a safe, orderly, clean work environment. Reports all accidents to the supervisor. Ensures all PPE (personal protective equipment) is used, as required
Adheres to cGMP guidelines, SOP’s and plant policies/guidelines. Assists in monitoring area for cGMP compliance
Perform other related duties or special assignments as directed by supervisor
Qualification
Required
Must pass written and practical area requirements for area/certification
Must have the ability to follow verbal and written instructions and read, understand, and communicate well with others in person and over the phone
Must have a working knowledge of mathematical calculations, such as adding, subtracting, multiplying, and dividing. Capable of working with fractions, decimals, and percentages. Must be able to input data into a computer, as required
Possesses good mechanical skills to handle lab equipment
Must be able to work independently and in a team environment. Must be dependable, competent and show good attendance
Must be a detail-oriented person. Requires strong focusing skills on in-process work activities to detect irregularities
Adapts positively to a changing environment and/or situation
Must be able to maintain confidentiality with personal and business information
The incumbent will be expected to function independently with minimum supervision
Must be at least 18 years of age
High School Diploma required
Minimum one years' experience as a production operator or similar production or quality experience
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase