Senior Quality Inspector

ICU Medical Inc.•Salt Lake City, UT

58d

About The Position

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.

Requirements

Excellent Mathematical knowledge
Good knowledge in records filing
Good computer knowledge
Ability to comprehend both verbal and written instructions
High School Diploma or GED required
Experience with medical devices/pharmaceutical GMPs preferred
Minimum of 2 years in a FDA regulated manufacturing environment
Must be at least 18 years of age

Nice To Haves

Experience with medical devices/pharmaceutical GMPs preferred

Responsibilities

Perform audits on each batch record to ensure completion and compliance (in hard copy or electronic version)
Execute final product release via iFactory / Oracle system
Access to Oracle Installed Base to update serial device information
Provides Manufacturing / MQA support to detect quality risks
Verify that the records documented are within the corresponding procedures
Demonstrate leadership, problem solving skills and technical knowledge with solid communication skills, attitude, dedication and commitment
Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FQA, EPA, FDA, OSHA, ISO, EEPC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate)
File and retain batch records in controlled area per retention procedure
Ability to troubleshoot and work in a team environment
Other activities related to the position