Engineer II Quality Event Managementield Safety

at  Arthrex

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Engineering or Engineering Technology required.
• 2+ years’ experience with root cause analysis, project management and continuous improvement in a regulated environment.

KNOWLEDGE AND SKILL REQUIREMENTS/SPECIALIZED COURSES AND/OR TRAINING:

• Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required.
• Knowledgeable of medical device complaint handling and adverse event reporting requirements preferred.
• Knowledgeable of product risk management, CAPA, and Nonconformance Reporting preferred.
• Knowledgeable of orthopedic medical devices including implants, instruments, biologics, and electronical equipment preferred.

MACHINE, TOOLS, AND/OR EQUIPMENT SKILLS:

Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company). SAP and / or SmartSolve Quality Data experience desirable.

MATHEMATICAL SKILLS

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

LANGUAGE AND COMMUNICATION SKILLS:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

VISION REQUIREMENTS:

Visual acuity necessary to do the job safely and effectively.
Specific vision abilities required by this job include close vision using a microscope and light source.

• Develop and promote the Arthrex Product Surveillance processes for medical devices, including developing, managing and maintaining global policies and procedures.
• Perform root cause analysis for returned complaint devices or identified trends as appropriate.
• Maintain test protocols to evaluate returned product according to established specifications and record detailed results. Perform device evaluations when needed.
• Partner with Design Engineering, Manufacturing Engineering, Product Management, and Quality Engineering teams to drive continuous process and product improvement.
• Function as the global representative for complaint investigation, escalation, and trending processes during Agency/3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies.
• Provide timely customer feedback to key stakeholders through root cause analysis, statistical analysis and regularly scheduled forums.
• Support global complaint triage, intake, evaluation, reporting, investigation, closure and trending activities.
• Manage supplier relationships from initial notification to receipt of a supplier complaint evaluation.