Post Market Complaints Engineer

Skills Alliance; Gainesville (FL); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Complaint investigation

Root cause analysis

Regulatory knowledge

Team collaboration

Jobbeschreibung

Complaints Engineer | Post-Market Surveillance | Orthopedics

Job Type: Full-time, Permanent

A growing orthopedic medical device company is expanding its Post Market Surveillance function. The company designs and manufactures implants and instruments used by surgeons across the US and internationally, and its quality system is built on FDA and ISO requirements. As part of this expansion, it is hiring a Complaints Engineer to investigate product issues from the field and work out what went wrong. The role will keep products safe, the business compliant, and engineering informed.

What you'll do:

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

What you'll bring:

• Orthopedic implant or instrument experience, or Class III medical device experience from another area (cardiac, dialysis, surgical robotics)
• 5 years or more in complaint investigation
• Hands-on investigation experience, including root cause and risk analysis on complex cases
• Working knowledge of FDA and ISO quality system regulations (ISO 13485, 21 CFR 803, 806 and 820)
• A team-first mindset with an entrepreneurial streak, and the ability to hit the ground running with limited ramp-up

This is a chance to join a Post Market Surveillance team during a period of real growth. You'll work on real product issues rather than paperwork, and help shape how complaints and investigations are handled as the function scales.