Viant, a leading manufacturer of medical devices, is looking for a contract Quality Inspector to join their 1st shift team in Indianapolis, IN. The primary purpose of this position is to perform standardized measurements of parts in-process involving prescribed measurement tools under guided supervision. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols.
- 80,000 sq. ft.
- Two 5-axis CNC machines, six 3-axis CNC machines, thermoforming machine
- FDA registered; ISO 13485 certified
- CNC turning & milling
- Metal forming/bending
- High School diploma or equivalent
- 2+ years of experience in manufacturing or regulated industry
- Ability to read and interpret drawings/prints
- Basic knowledge in the use of hand gages, tool scopes and height stands
- Experience measuring physical dimensions on parts.
- Ability to interpret and apply GD&T to measurement methods
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Key Accountabilities and Responsibilities:
- Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Uses standard measuring tools, measuring machines, and electronic instruments to perform inspections in accordance with authorized specification and quality control standards.
- Performs analysis using standard or custom procedures to make accept/reject decisions.
- Performs basic troubleshooting, as necessary. Develops solutions for technical problems of limited scope.
- May repair, modify and/or maintain systems and measurement equipment
- Sets up and runs measurement systems with direction.
- Uses judgement and problem-solving skills to provide input in the evolution of measurement equipment, systems and processes.
- Works in individual and team settings with guidance as needed.
- Prepares necessary documentation and ensures paperwork compliance on all inspected items, including filing, scanning and verification of device history records.
- 1Interacts professionally with other departments to provide data, analysis results and decisions.
- Performs other functions as required.
About the company: With over 35 years of medical device molding experience, Viant has become a comprehensive solutions provider for single use medical devices. Services range from concept and design of components to assembly of finished products. They are headquartered in Foxborough, MA and operate 17 manufacturing facilities in the US, with additional locations in China, Mexico, Costa Rica, Puerto Rico, France, Germany and the UK.
All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.