Requisition ID: 49851 Title: Design QA Engineer
Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We design and manufacture Class I, II, III devices. Arthrex is actively seeking a Design Quality Engineer
Responsible to manage specific aspects of the Arthrex risk management program with an emphasis on patient safety, and harm reduction. This position will play a critical role in the risk management efforts. In coordination with the Supervisor, Risk Management and Pre-Operative Planning, this role will design, coordinate and maintain various aspects of the patient safety and risk management programs for Arthrex.
Essential Duties and 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;
Facilitate and lead Field Action Advisory Committee (FAAC) meetings, ensuring recordable events are appropriately documented, communicated, and dispositioned, with outputs implemented back into design and/or quality management system procedures & processes;
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.
Support the development of test plans, design documentation reviews, and risk mitigation execution.
Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards.
0 - 2 Years' experience in a regulated environment.
BS Degree in Engineering or Engineering Technology required.
Previous project leadership experience preferred.
Knowledgeable of Regulatory and ISO guidelines for the development of medical devices preferred.
Manufacturing process knowledge preferred.
Project management and communication skills training preferred.
Working knowledge of risk management requirements preferred.
Solves routine problems of limited scope and complexity following established policies and procedures.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
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 Pilgrim Quality Data experience desirable.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.