Performs complaint product analysis and root cause investigation in support of Advita and regulatory requirements, product improvement, and issue escalation. Key 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, 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. Skills Knowledge and Expertise Education: • Bachelor’s Degree in an Engineering discipline from an accredited institution required; degree in Mechanical or Biomedical Engineering, or a Master’s Degree preferred. Experience: • Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical engineering design, root cause and risk analysis, and technical writing. • Previous experience in the Medical Device or Pharmaceutical FDA regulated environment preferred. • Experience with FDA/ISO quality management system regulations preferred. Functional/Technical Knowledge, Skills and Abilities Required: • Must have excellent communication (verbal & written) and organizational skills. • Must have excellent interpersonal skills and must be able to work effectively in a team environment. • Must be detail-oriented and have the ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform analyses with accuracy. • Strong organizational and time management skills. • Self-directed; capable of setting own priorities and working independently to meet established deadlines. • Must be creative and have the ability to independently apply theoretical technical principles to product design. • Must have knowledge of various software packages including Microsoft Office applications. • To fully meet team responsibilities, the individual will develop additional knowledge and skills in anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.