The posting
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.
