Post Market Quality Engineer

Responsibilities

• Investigate medical device field complaints and provide solutions in a timely manner
• Perform failure analysis of medical devices using test equipment, fixtures, and software tools
• Conduct root cause analyses and risk analyses for product field failures
• Review device history records, material certifications, and inspection reports for conformance
• Work with Product Line Engineers to complete post market risk assessments
• Develop and maintain Job Aids and Work Instructions to standardize investigation activities
• Interface with external auditors

Requirements

• Bachelor’s degree in an Engineering discipline or equivalent experience
• Thorough knowledge of specifications, dimensions, tolerances, and GD&T
• Proficiency in statistical applications and SPC
• Knowledge of non-destructive testing and measuring techniques
• Strong working knowledge of medical device quality regulations (21CFR820, ISO 13485, ISO 14971)
• Excellent technical writing and analytical skills
• Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint)
• Valid driver’s license

Preferred Qualifications

• 5 years of Medical Device Quality experience
• ISO 13485 Audit Certification
• ASQ certification

About the Company

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics, providing a comprehensive product offering to improve the lives of children with orthopedic conditions.