Design Quality Engineer Sr I - Risk Management

Hongkang Northamerica • Naples, FL

116d

About The Position

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 Senior Design Quality Engineer - Risk Management for our Global Headquarters in Naples, FL. The Sr. DQE will manage specific aspects of the Arthrex risk management program with an emphasis on patient safety, and harm reduction. In coordination with the others in the department, this role will design, coordinate and maintain various aspects of the patient safety and risk management programs for Arthrex. The ideal candidate will have a BS in Engineering, and 5+ years Risk Management experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

• Bachelor's degree in Engineering required
• 5+ years' risk management experience required
• Previous project leadership experience required
• Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required.
• Experience in working with product risk management, CAPA, Complaint Management, and Nonconformance Reporting required.

Nice To Haves

• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of risk management requirements.
• Working knowledge of device clinical use and associated harms and hazards.
• Knowledge of orthopedic surgery principles, theories, and products preferred.
• Historical perspective on risk management programs and requirements preferred.
• Personnel supervision experience preferred.
• Experience in project management, risk management (such as FMEA, FTA, FMECA) tools are highly desirable.

Responsibilities

• Develop and promote the Arthrex Risk Management processes for medical devices, including developing, managing and maintaining global policies and procedures.
• Create, manage, and maintain device risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements part of the device design process.
• Generate Event Risk Assessments (ERAs) to appropriately document and disposition patient and/or user health hazards arising from product complaints or non-conformances.
• Partner with Design Engineering and Program Management to ensure appropriateness and adequacy of quality management system documentation facilitating design and development planning and execution.
• Function as the global representative for Arthrex Risk Management process 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.
• Collect and analyze product design and quality data to facilitate generation of lessons learned, improvement of processes, and assurance of patient safety.
• Participate in program design reviews and ensure risk traceability to design requirements and risk mitigations are clearly documented and maintained.
• Provide guidance and support to design and manufacturing teams in the generation of risk source documentation, e.g., dFMEA, pFMEA, Fault Tree Analysis, etc.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree