Job Title: Mechanical Inspector
Location: Salt Lake City UT 84123
Duration: 12 Months
Shift timing/schedule: 12 hr. rotating shift 6:30AM6:30PM
Understanding of measurement theory and practices including geometric dimensioning and tolerancing (GD&T) per ASME Y14.5
Summary:
The Mechanical Inspector performs quality inspections of subassemblies final product and commodities including dimensions visual and physical attributes. Responsible for performing complex repetitive quality tasks. The tasks for which this individual is responsible are typically comprised of singlestep operations for the part measurement program. Also is responsible to ensure that medical devices are measured and inspected with the highest quality possible. Provide support to quality lead as needed. Create measurement inspection plans for molded components and validations.
Essential Duties & Responsibilities
- Recognize and communicate deviations from accepted practices in all areas of quality review.
- Read interpret and understand drawings and specifications.
- Use hand gauges for inspections (calipers micrometers height/depth gauges etc..
- Product sampling and subsequent part inspection according to specifications.
- Report and generate material nonconformance lot reports (NLRs).
- Follow cGMP.
- Create robust inspection plans and/or routines.
- Perform First Article and Validation Inspections.
- Perform Gauge R&R when needed.
- Using SPC software analyze statistical data.
- Work on special projects as they arise.
Knowledge Skills & Qualifications
- Strong knowledge of Plastic Processing.
- cGMP knowledge.
- Basic math skills.
- Basic computer knowledge.
- Strong written and verbal communication skills.
- Familiarity with ASTM Standards a plus.
- Familiarity with ISO 9001 and Medical Manufacturing Environments a plus.
- Must be detail oriented and follow instructions and specification meticulously.
- Knowledge of SPC software preferably Prolink QCCalc.
- Ability to program smart scope software preferably QVI Zone 3 Measuremind3D and Zeiss Calypso.
- Understanding of measurement theory and practices.
Education and Experience
- High School diploma or equivalent.
- Minimum 4 years of experience performing measurement inspections in an FDA regulated manufacturing environment preferably medical device components.
- Minimum 2 years of experience creating automated routines with smart scope software.
Travel Requirements
- Typically requires travel less than 5 of the time.
Physical Requirements and Work Environment
- Work is performed in a clean room environment.
- While performing the duties of this job the employee may be required to sit or stand for long periods of time; depending on the machine they are operating.
- Operator is required to use computer or touch screen to enter work order data.
- Must be able to occasionally move and lift objects of up to 25 lbs.