Description
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
• Must be 18 years of age
• Must pass pre-employment drug screen and background check
Travel Requirements
• Typically requires travel less than 5% of the time
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.
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