Quality Systems & Regulatory Comp Associate
INC- Naples, FL
Responsible for supporting the Quality Systems and Regulatory Compliance (QSRC) department with quality related support for improving and maintaining the Arthrex global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements.
Essential Duties and Responsibilities: Responsible for participating in QSRC projects to assure the Arthrex QMS meets all requirements. Participate in Internal and External quality audits as directed by the QSRC Manager. Responsible for writing and/or assisting in the writing of Arthrex QMS SOPs. Responsible for assisting in compiling, tracking and reporting on Arthrex QMS / Compliance metrics. Provide support / consultation to the users of QMS software / procedures. Assist in providing QMS training, education and guidance to the Arthrex organization. Assist in investigating, documenting, and implementing actions for QMS issues. Assist in generating/creating reports against determined measurement criteria within the QMS. Assist in developing enhancements, as needed, for the process and application tools within the QMS. Providing backup support for QMS coordination. In QSRC Supervisor/Manager absence, serve as initial contact for QSRC issues. May participate in compliance audits according to the QSR, ISO or other applicable standards. Assist in educating Arthrex Organization on QSR’s and ISO standards. Support the QSRC Department with respect to evaluations, investigations, and implementations of QMS items. Assist in implementing QSRC improvements and supports ongoing continuous improvement efforts.
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.
Education and Experience:
Bachelor’s Degree in Engineering or Science Related study, or related areas required.
At least five years’ experience in an FDA /ISO regulated environment.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Experience in project management, Lean, Six Sigma, DMAIC and other quality tools are highly desirable. Experience in working with CAPA, Complaint Management, or Nonconformance Reporting required.
Machine, Tools, and/or Equipment Skills:
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.
Location/Region: Naples, FL (US)