Quality Inspector Ii

Description:

Performs inspections of outsourced and internal finished and semi- finished
medical devices, components, and raw materials to ensure that the product complies with
product quality plans, specifications, and requirements.

Requirements:• Solid understanding and experience using calipers, micrometers, hard gauging, and
other applicable inspection tools.
• Experience and able to operate vision and optical measuring equipment such as
Starrett, Keyence, etc.
• Must be familiar with engineering drawings.
• Must have solid understanding of Geometric Dimensioning & Tolerancing.
• Strong working knowledge of various mathematical concepts including fractions, ratios,
and proportions.
• Ability to lift and/or move 25 pounds occasionally.
• Specific vison abilities required include close vision, distance vision, color vision,
peripheral vision, depth perception, and the ability to adjust focus.
• Demonstrated ability to work independently with minimal supervision.
• Excellent organizational skills.
• Demonstrated ability to analyze and interpret information.
• Ensure compliance with federal and state laws, as well as company standards and
specifications.
Perform visual, functional, and dimensional inspections across all stages of production.
• Communicate quality or concerns with urgency.
• Applies Good Manufacturing Principles (GMP) in all areas of responsibility including
21CFR820, ISO13485, EU MDR, MDD and CMDR Standards and regulations.
• Corrects or escalates quality or compliance concerns.
• Follows all Tyber Medical, LLC Standard Operating Procedures.
• Responsible for preventative maintenance activities
• Other Duties as assigned