Orthopedic Medical Device Post‑Market QA Engineer

Advita Ortho, LLC; Gainesville (FL); On-site; USD 70,000 - 100,000; Full time

Job summary

Advita Ortho, LLC is seeking a quality investigation engineer in Gainesville, FL to perform complaint product analysis and root cause investigations in support of regulatory requirements and product improvement.

The role involves collaborating with cross-functional engineering teams, documenting activities, and supporting audits, CAPAs, and quality processes as part of continuous improvement of orthopedic implants and instruments.

Qualifications

• Bachelor’s degree in an Engineering discipline from an accredited institution required; Mechanical or Biomedical Engineering preferred.
• Basic understanding of mechanical drafting, GD&T, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical design, root cause and risk analysis, and technical writing.

Responsibilities

• Applies engineering problem-solving techniques during complaint investigations.
• Performs complaint product analysis and testing per procedures.
• Performs root cause analysis and risk analysis for complaints.
• Supports CAPAs, HHEs, NCRs and other quality processes as needed.
• Drafts investigation responses to customers and assists in procedures/documents.

Skills

Problem solving

Root cause analysis

Technical writing

Cross-functional collaboration

Attention to detail

Time management

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

CAD

Microsoft Office

Job description

Advita Ortho, LLC is seeking a quality investigation engineer in Gainesville, FL to perform complaint product analysis and root cause investigations in support of regulatory requirements and product improvement.

The role involves collaborating with cross-functional engineering teams, documenting activities, and supporting audits, CAPAs, and quality processes as part of continuous improvement of orthopedic implants and instruments.