Engineering Co-op - Quality Assurance - Product Surveillance

Main Objective:

To support the Product Surveillance team with medical device complaint handling, investigation, and data analysis.

Essential Duties and Responsibilities:

• Receive and analyze previous complaint data and leverage for future investigations.
• Assist with data gathering and analytics for monthly complaint trending activities.
• Perform root cause analysis for returned complaint devices or identified trends as appropriate.
• Support global complaint triage, intake, evaluation, reporting, investigation, closure and trending activities.
• Partner with design, manufacturing and quality engineers as well as product management teams to drive continuous process and product improvement.
• Review of Supplier Quality Agreements and incorporation of information into electronic complaint system.
• Other duties as assigned.

Education and Experience:

• Enrolled as a full-time student pursuing a bachelor's degree in engineering or engineering technology, or a recent engineering or engineering technology graduate, required. Junior or above, studying Mechanical or Biomedical Engineering preferred. (Recent graduates must be within six months of their graduation date to qualify.)

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Ability to effectively communicate, oral and written, and possess the ability to work through technical issues.
• Knowledge of Regulatory and ISO guidelines pertaining to medical devices preferred.
• Basic knowledge of product risk management, CAPA, and Nonconformance Reporting (NCR) preferred.
• Knowledge of orthopedic medical devices (implant, instruments, biologics, etc) preferred.

Machine, Tools, and/or Equipment Skills:

PC; Familiarity with Microsoft Office Suite preferred.