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Quality Inspection Technician
- Indianapolis, Indiana, United States
- Indianapolis, Indiana, United States
Über
General Purpose:
The Quality Inspection Technician is responsible for examining materials for quality and defects. Ensures that the Manufacturing Procedures and Quality procedures are followed to maximize productivity.
Essential Job Duties and Responsibilities
The essential functions include, but are not limited to, the following. Other duties may be assigned as necessary. (While working in the manufacturing environment, all gowning policies, personal protective equipment (PPE) requirements, safety procedures, and cleanliness/hygiene standards must be strictly followed.)
- Ensure all manufactured goods meet company quality standards, regulatory requirements, and customer specifications.
- Inspect incoming materials, in-process components, and finished products for conformance to defined criteria using visual checks, templates, gauges, and testing instruments.
- Conduct product testing and analysis using tools such as thermometers, voltmeters, moisture meters, and tensiometers; record and interpret data accurately.
- Monitor equipment operation by observing dials, gauges, and indicators to confirm performance within specified parameters.
- Identify, document, and report nonconformances or process deviations; support corrective and preventive actions.
- Maintain accurate inspection records, test data, and pass/fail documentation within quality management systems.
- Participate in audits, process reviews, and continuous improvement initiatives to enhance product quality and operational efficiency.
- Verify compliance with manufacturing codes, internal policies, and industry standards.
- Assist with ordering or coordinating replacement materials and ensuring proper labeling, segregation, and handling of approved and rejected items.
- Support training, documentation, and communication of quality expectations across teams.
- Perform other related duties assigned by management.
Skills, Education and Experience:
- High School diploma or equivalent required.
- 1 year of experience in medical device environment preferred.
- Knowledge of document control systems, FDA 21 CFR Part 820, ISO 13485, and Good Documentation Practices (GDP).
- Strong attention to detail, organizational, and communication skills.
- Proficient in Microsoft Office and quality management software.
- Ability to manage multiple priorities while maintaining accuracy and compliance.
Physical Requirements
- Periods of sitting and working at a computer.
- Must be able to push, pull, or lift up to 50 pounds.
- Ability to move between office, production, and engineering lab areas as needed.
- Ability to sit and/or stand for extended periods of time.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Sprachkenntnisse
- English
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