Quality Inspector - Mechanical

Job Title: Quality Inspector - Mechanical

Location: 4455 Atherton Drive, Salt Lake City, UT, 84123

Duration: 12 Months

Shift : B1 (12 hr) rotating shift|6:30AM - 6:30PM

Position Summary:

• The Mechanical Inspector performs quality inspections of sub-assemblies, 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 single-step 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 non-conformance lot reports (NLR’s).
• 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 QC-Calc
• Ability to program smart scope software, preferably QVI Zone 3, Measuremind3D and Zeiss Calypso
• Understanding of measurement theory and practices
• Understanding of measurement theory and practices including geometric dimensioning and tolerancing (GD&T) per ASME Y14.5
• Ability to program smart scope software, preferably QVI Zone 3, Measuremind3D and Zeiss Calyps
• Experience with Gage R&R, first article, and validation inspections

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

Minimum Qualifications:

• Must be at least 18 years of age

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.

Job Type: Contract

Pay: $20.00 - $21.00 per hour

Schedule:

• 12 hour shift

Shift availability:

• Day Shift (Preferred)

Work Location: In person

Salary : $20 - $21