Quality Engineer II Product Surveillance

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Quality Engineer II, Product Surveillance who is responsible for driving product improvements through performing and supporting Product Quality Complaint evaluations and investigations, analyzing and trending Product Quality Complaint data, and providing timely customer feedback to key stakeholders.  The ideal candidate will have a Bachelor’s degree in Engineering and 2+ years’ experience with root cause analysis, project management and continuous improvement in a regulated environment.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• 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.

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.

Reasoning Ability:

Ability to identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must frequently bend and lift/move up to 10 pounds.  The employee must occasionally bend and lift/move up to 50 pounds.

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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.  The noise level in the work environment is usually moderate.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.