Inspection Quality Technician

About the Company

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. The company has developed the most comprehensive product offering in the pediatric orthopedic market, improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products spanning trauma and deformity, scoliosis, and sports medicine/other procedures. Its global sales organization distributes products in the United States and over 70 countries.

About the Role

The Inspection Quality Technician provides hands-on expert technical support for product quality inspection, inspection test method development, and product acceptance activities. This position also supports the assembly of medical device surgery trays/kits as needed.

Responsibilities

• Assist in the development, implementation, and monitoring of product quality inspection requirements.
• Perform product inspection activities to ensure conformance to product specifications.
• Assist in the development and maintenance of product quality inspection-related SOPs and Work Instructions.
• Participate in CAPA (Corrective and Preventive Action) activities.
• Assist in MSA (Measurement System Analysis) and Gauge R&R (Gage Repeatability and Reproducibility) studies.
• Act as a subject matter expert for daily operations quality functions.

Requirements

• Minimum of 3 years of inspection experience in the medical device field.
• Detailed knowledge of non-destructive product testing/inspection techniques.
• Skilled in the use of inspection and metrology equipment such as micrometers, calipers, optical comparators, go/no-go gauging, and others.
• Prior experience developing and maintaining product quality inspection-related SOPs and Work Instructions.
• Strong working knowledge of medical device quality system regulations and standards, including 21 CFR 820, ISO 13485, and EU MDR.
• Detailed knowledge of GD&T (Geometric Dimensioning and Tolerancing) and the ability to accurately interpret part drawings/prints.
• Excellent verbal and written communication skills.
• Ability to work in a strong team environment and solve problems.
• Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Valid driver’s license.

Qualifications

• ASQ certification preferred.
• Knowledgeable in gauging methods and their applications, as well as product inspection.
• Ability to read, comprehend, and prepare routine reports and correspondence.
• Strong mathematical skills, including the ability to perform calculations using whole numbers, fractions, and decimals.
• Ability to follow written, oral, or diagrammed instructions and use critical thinking to address problems with multiple variables.

Physical Demands

• Regularly required to sit and use hands to finger, handle, or feel.
• Frequently required to climb stairs, talk, and hear.
• Occasionally required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl.
• Must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.

Work Environment

• Noise level in the work environment is typically that of a normal office, though visits to other locations in the building may involve moderate to occasionally loud noise.
• Occasional work-related travel may be required.