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 Product Surveillance Technician I who works with a team to evaluate medical device products to determine if investigations are required. The Technician will also support investigations when required while following all applicable FDA 21 CFR 820 regulations and ISO 13485:2016 standards. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

•  Conducts complaint evaluations and investigations and ensures all findings are properly documented
•  Evaluate and test returned product according to established specifications, drawings, and procedures
•  Collect and record data in appropriate formats as part of continuous improvement
•  Perform functional testing according to measurement and analysis procedures and or pass/fail criteria
•  Confirm by objective evidence any non-conformances reported or observed with the product
•  Works with various Engineering teams to facilitate complaint investigations based on technical complexity and determine   non-conformance root  cause(s)
•  Works with vendors to ensure vendor evaluations and investigations are timely and complete
•  Works with Product Surveillance personnel to resolve discrepancies in complaint files
•  Analyze historical complaints and investigations for trending analysis
•  Use risk analysis tools to evaluate product and system safety issues in accordance with procedure
•  Identify and present quality issues with risk based prioritization
•  Maintains complaint investigation lab to internal and OSHA requirements

Education and Experience:

• High School or equivalent required
• Experience in a regulated environment preferred

Skills and Knowledge:

Experience collecting and documenting data

Ability to work independently or pn a team to assure functional commitments are met

Strong analytical skills, and ability to process data and draw appropriate conclusions

Experienced in trending data

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and MS Office programs, particularly MS Excel and MS Word preferred.

Familiarity with electrical and mechanical testing tools and methods preferred.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of writings, technical instructions in mathematical or diagram form, communications, 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 to sit, use hands and fingers to handle or feel, and reach with hands and arms. The employee must occasionally lift and/or 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.

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.