Product Surveillance Technician I

Hongkang Northamerica-posted 4 months ago

Naples, FL

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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™.

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

High School or equivalent required
Experience in a regulated environment preferred
Experience collecting and documenting data
Ability to work independently or on a team to assure functional commitments are met
Strong analytical skills, and ability to process data and draw appropriate conclusions
Experienced in trending data

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

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)

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