About this role
Performs complaint product analysis and root cause investigation in support of Advita and regulatory requirements, product improvement, and issue escalation. 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, as appropriate and per Advita's procedures and requirements. Collaborates with cross-functional engineering teams to ensure thorough investigations and appropriate escalations. Documents all complaint investigation and escalation activities per Advita's procedures and requirements. Provides design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market as part of continuous improvement. Supports CAPAs, HHEs, NCRs, and other quality processes, as needed. Supports the completion of complaint activities in line with department metrics and key performance indicators. Supports audits and audit requests for complaints. Drafts investigation responses to customers, as requested. Supports the drafting and revision of procedures, work instructions, forms, technical documents, and protocols. Supports continuous improvement activities. Assists in training complaint team members. Know and applying Advita’s Quality System and any appropriate FDA and international standards. Assist and support other employees, teams, and sales personnel as necessary.