Senior Orthopedic Post-Market Complaints Engineer

Skills Alliance; Gainesville (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Skills Alliance is expanding its Post-Market Surveillance team and seeks a Complaints Engineer to investigate complex field issues and determine root causes for orthopedic implants or instruments. The role emphasizes risk analysis, CAPAs, and regulatory compliance to ensure patient safety and regulatory alignment.

You will work with engineering peers to drive investigation quality, support audits, and help evolve complaint processes as the function scales.

Qualifications

• Orthopedic implant or Class III medical device experience is required.
• Minimum 5 years in complaint investigation.
• Hands-on investigation experience including root cause and risk analysis.

Responsibilities

• Investigate complex, high-severity complaint events with product analysis and testing.
• Carry out complaint risk analysis and review complaint history to spot trends.
• Own or support CAPAs, HHEs and NCRs, escalating findings per FDA/ISO requirements.
• Draft and update procedures, work instructions, and investigation responses.
• Collaborate with cross-functional engineering teams to close investigations.
• Support audits and act as the go-to expert on complaint activity.
• Train complaint team members and contribute to continuous improvement.

Skills

Complaint investigation

Root cause analysis

Regulatory knowledge

Team collaboration

Job description

Skills Alliance is expanding its Post-Market Surveillance team and seeks a Complaints Engineer to investigate complex field issues and determine root causes for orthopedic implants or instruments. The role emphasizes risk analysis, CAPAs, and regulatory compliance to ensure patient safety and regulatory alignment.

You will work with engineering peers to drive investigation quality, support audits, and help evolve complaint processes as the function scales.