Post-Market Surveillance Engineer – Medical Devices QA

Advita Ortho; Gainesville (FL); On-site; USD 85,000 - 110,000; Full time

Job summary

Advita Ortho is seeking a Post Market Surveillance Engineer in Gainesville, FL to lead complaint investigations and root cause analyses for orthopedic implants and instruments. The role integrates cross-functional collaboration, documentation, and adherence to regulatory requirements to drive product quality.

The position requires a Bachelor's degree in Engineering and familiarity with QMS regulations; strong writing, communication, and organizational skills are essential for audits and

Qualifications

• Bachelor’s degree in Engineering required; Mechanical or Biomedical preferred.
• Basic understanding of mechanical drafting, geometrical dimensioning and tolerancing, CAD, statics/dynamics, mechanics of materials, root cause and risk analysis, and technical writing.
• Experience in Medical Device or FDA-regulated environment preferred; FDA/ISO QMS knowledge beneficial.

Responsibilities

• Applies sound engineering problem-solving techniques during complaint investigation activities.
• Performs complaint product analysis and testing per Advita's procedures and requirements.
• Performs complaint root cause analysis.
• Performs complaint risk analysis and complaint history reviews.
• Escalates complaint investigation findings per procedures.
• Collaborates with cross-functional engineering teams to ensure thorough investigations.
• Documents all complaint investigation and escalation activities per procedures.
• Provides design, engineering, and analysis support for orthopedic implants and instruments in market as part of continuous improvement.
• Supports CAPAs, HHEs, NCRs, and other quality processes as needed.
• Supports audits and audit requests for complaints.
• Drafts investigation responses to customers.
• Supports drafting and revision of procedures, work instructions, forms, and protocols.
• Supports continuous improvement activities.
• Assists in training complaint team members.
• Applies Advita’s Quality System and FDA/ISO standards.

Skills

Communication

Teamwork

Detail-oriented

Time management

Independent work

Technical writing

Microsoft Office

Education

Bachelor’s degree in Engineering

Tools

CAD

Job description

Advita Ortho is seeking a Post Market Surveillance Engineer in Gainesville, FL to lead complaint investigations and root cause analyses for orthopedic implants and instruments. The role integrates cross-functional collaboration, documentation, and adherence to regulatory requirements to drive product quality.

The position requires a Bachelor's degree in Engineering and familiarity with QMS regulations; strong writing, communication, and organizational skills are essential for audits and