Quality Engineer, Medical Devices (Pediatrics)

OrthoPediatrics Corp.; Warsaw (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

OrthoPediatrics Corp. in Warsaw, IN seeks a Quality Engineer to lead quality improvements and support NPD, while maintaining legacy systems. You will partner with cross-functional teams to select high-quality manufacturers and conduct supplier audits.

Responsibilities include developing quality plans, documenting form/fit/function data, cost analysis, and implementing corrective actions. Strong analytical and communication skills are essential, with knowledge of 21 CFR 820 and ISO 13485.

Qualifications

• Bachelor degree in a related engineering field is required.
• ASQ certification is preferred.
• Experience with medical device quality systems (21 CFR 820, ISO 13485) is expected.

Responsibilities

• Develop and monitor adherence to product quality plans.
• Create documents detailing form, fit and function for quality decisions.
• Provide quality costing information and trend analysis.
• Identify approved gauging and measurement techniques.
• Specify measurement equipment and improve gauging methods.
• Ensure compliance with internal and customer quality standards.
• Reduce cost by reducing non-conforming materials or products.
• Diagnose quality problems and implement improvement programs.
• Conduct supplier and internal quality audits.

Skills

Team collaboration

Product knowledge

Statistical methods (SPC)

Non-destructive testing

Verbal and written communication

Data interpretation

Design of experiments

Problem solving

Quality system regulations

Education

Bachelor degree in Industrial Engineering or related field

ASQ certification preferred

Tools

MS Excel

MS Word

MS PowerPoint

Job description

OrthoPediatrics Corp. in Warsaw, IN seeks a Quality Engineer to lead quality improvements and support NPD, while maintaining legacy systems. You will partner with cross-functional teams to select high-quality manufacturers and conduct supplier audits.

Responsibilities include developing quality plans, documenting form/fit/function data, cost analysis, and implementing corrective actions. Strong analytical and communication skills are essential, with knowledge of 21 CFR 820 and ISO 13485.