ICU Medical Inc. Salt Lake City , UT 84101
Posted 2 months ago
Position Summary
Performs first article inspections level I and II of in-house and outside components, mold start-up inspection for critical dimensions, as well as visual and physical attributes, Engineering evaluations and mold validations. This individual proactively communicates verbal and written reports of product validations. Fulfills miscellaneous measurement and visual requests and communicates results. Sustain and maintain department quality records and reports.
Essential Duties & Responsibilities
Keep work area and equipment clean
Experienced in the use of SmartScopes or vision systems and writing efficient and accurate routine/programs
Able to read and understand procedures
Strong verbal and written communication skills.
Ability to communicate thoughts and ideas interdepartmentally (Eng., Quality, Production)
Perform inspection to ensure good quality
Recognize and communicate deviations from accepted practices.
Product sampling and subsequent part inspection according to specifications
Must be motivated and capable of dictating priorities when needed
Ability to adapt to changes in project priorities
Understands and follow cGMP
Assist QA Inspectors and Molding personnel in the interpretation of part drawings, specifications and QA standards.
Trains Molding QA personnel on measurement methods and to execute routines
Strong collaboration with engineering and design team for solutions and/ or new ideas
Other duties as assigned
Knowledge, Skills & Qualifications
Basic Microsoft (Outlook, Excel, Word) and computer experience.
Able to read and understand procedures
Ability to learn and understand new routine program software
Basics of part fixture design
Basics of statistics; such SPC and Gage R&R
Basic Math skills ( Basic Algebra)
Strong verbal and written communication skills
Advanced knowledge in reading, interpreting, and understanding drawings and specifications
ASQ Certified Inspector Certification a plus
Experienced in the use of hand gauges (calipers, micrometers, height/depth gauges, etc.)
Capable of making Quality decisions (within allowable limits) to ensure good quality product.
Able to perform complex visual and functional tests and investigations on product. Capable of using test and investigation data to determine appropriate course of action on product.
Occasional backup for team lead.
Demonstrate leadership, problem solving skills and technical knowledge.
Education and Experience
High school diploma or GED required
Minimum of 3 years in a quality control environment or FDA regulated manufacturing environment or ASQ/CQI Certification
Minimum of 1 year developing measurement routines in vision systems
Minimum Qualifications
Travel Requirements
Physical Requirements and Work Environment
Must be able to perform visual inspections with and without the aid of magnification tools
While performing the duties of this job, the employee is regularly required to talk or hear.
This job operates in a clean room environment.
While performing the duties of this job, the employee may be required to sit or stand for the duration of the shift
Must be able to repetitively move and lift objects of up to 30 lbs
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
ICU Medical Inc.