Quality Inspector III

Quality Inspector III - Immediate Temporary Position!

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

Responsibilities: Primary Duties

• Ensure compliance to federal and state laws, as well as company standards and specifications.
• Perform visual, functional and dimensional inspections across all stages of production.
• Train others on drawing requirements.
• 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

Skills and Qualifications:

• Solid understanding and experience using calipers, micrometers, hard gauging and other applicable inspection tools.
• Must be familiar with engineering drawings.
• Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions.
• Ability to lift and/or move 25 pounds occasionally.
• Specific vision 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.
• Basic GD&T Knowledge.

Education/Experience:

• Two-year college degree or equivalent medical devise/ QA experience or equivalent combination of education and experience.
• Minimum of 1-2 years of inspection and/or production experience.
• Previous medical device manufacturing experience and a working knowledge of FDA QSR and ISO 13485 preferred.