Quality Engineer: Medical Device Quality & Compliance

OrthoPediatrics; Warsaw (KY); On-site; USD 70,000 - 95,000; Full time

Job summary

OrthoPediatrics is seeking a Quality Engineer to develop and implement improvements to product quality and quality systems, supporting NPD teams and legacy maintenance. You will collaborate with cross-functional teams to select manufacturing partners and conduct supplier audits.

Responsibilities include establishing quality plans, product documentation, and data-driven analysis to prevent defects, while ensuring compliance with 21 CFR 820 and ISO standards in a medical device environment.

Qualifications

• Bachelor's degree in Industrial Engineering, Industrial Technology, Mechanical Engineering, Engineering Technology or related field.
• ASQ certification preferred.
• Must have computer skills; MS-Excel.
• Knowledgeable in gauging methods and their applications.

Responsibilities

• Develop, implement, and monitor adherence to product quality plans.
• Develop product documents to establish form, fit and function information for quality decisions.
• Provide quality costing information and analysis to monitor quality and identify unfavorable trends.
• Identify approved gauging and measurement techniques.
• Specify measurement equipment and improve gauging methods.
• Ensure compliance with internal and customer imposed quality standards.
• Reduce cost by eliminating or reducing non-conforming materials and/or products.
• Diagnose and assist in the resolution of quality problems and implement programs to improve product quality.
• Conduct supplier and internal quality system audits according to established schedules and quality standards.

Skills

Teamwork

Product knowledge

Statistics / SPC

Non-destructive testing

Communication skills

Data interpretation

Designed experiments

Problem solving

Regulatory knowledge

Education

Bachelor's degree in engineering related field

Tools

MS Excel

Microsoft Word

PowerPoint

MS Outlook

Job description

OrthoPediatrics is seeking a Quality Engineer to develop and implement improvements to product quality and quality systems, supporting NPD teams and legacy maintenance. You will collaborate with cross-functional teams to select manufacturing partners and conduct supplier audits.

Responsibilities include establishing quality plans, product documentation, and data-driven analysis to prevent defects, while ensuring compliance with 21 CFR 820 and ISO standards in a medical device environment.