What are the responsibilities and job description for the Quality Systems Auditor II position at Arthrex GmbH?
Requisition ID: 61873 Title:Quality Systems Auditor IIDivision:Arthrex, Inc. (US01)Location:Naples, FL
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 Systems Auditor II for our Global Headquarters in Naples, Fl. The Quality Systems Auditor II will perform Internal Quality System Audits to evaluate and determine conformance to industry standards and regulations pertaining to the development, manufacture, and distribution of medical devices. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties And Responsibilities
Posess quality auditor competencies (i.e ISO 19011) preferred.
Working knowledge of current international regulations and standards for medical devices, including ISO 13485 preferred.
Knowledge of statistical processes and trending preferred.
Reasoning Ability
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to listen, understand the information provided, and follow instructions.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Arthrex Benefits
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 Systems Auditor II for our Global Headquarters in Naples, Fl. The Quality Systems Auditor II will perform Internal Quality System Audits to evaluate and determine conformance to industry standards and regulations pertaining to the development, manufacture, and distribution of medical devices. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties And Responsibilities
- Preparing for and performing internal quality audits
- Applying applicable regulations to organizational processes
- Issuing nonconformances and following up on the effectiveness of corrections
- Writing and distributing audit reports
- Travel, as needed
- Track and trend quality audit data
- Analyzes processes and collaborate to identify opportunities for improvements and efficiencies.
- Collaborate with process owners to confirm Arthrex procedures and policies are compliant according to Arthrex Quality Management System requirements.
- Bachelor’s degree required
- 2 years Quality Auditing experience required
- Certified Quality Auditor or Qualified Lead Auditor preferred
Posess quality auditor competencies (i.e ISO 19011) preferred.
Working knowledge of current international regulations and standards for medical devices, including ISO 13485 preferred.
Knowledge of statistical processes and trending preferred.
Reasoning Ability
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to listen, understand the information provided, and follow instructions.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
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)
