Quality Systems & Regulatory Comp Spec

Main Objective:

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.  The primary focus of these activities will be in support of the Corrective and Preventive Action (CAPA) process.

Essential Duties and Responsibilities:

1. Responsible for participating in/leading QSRC projects to assure the Arthrex QMS meets all requirements.
2. Participate in compliance audits according to the QSR, ISO, or other applicable standards as directed by the Quality Systems Supervisor.  Functions as Back Room scribe/request coordinator during External audits.
3. Responsible for writing and revising Arthrex QMS SOPs.
4. Responsible for compiling, tracking and reporting on Arthrex QMS / Compliance metrics.
5. Provide support / consultation to the users of QMS software / procedures with primary focus on the CAPA process.
6. Provide QMS training, education and guidance to the Arthrex organization with primary focus on the CAPA process.
7. Investigate, document, and implement actions for QMS issues with primary focus on the CAPA process.
8. Generate/create reports against determined measurement criteria within the QMS with primary focus on the CAPA process.
9. Develop enhancements, as needed, for the process and application tools within the QMS with primary focus on the CAPA process.
10. Providing backup support for QMS coordination.
11. In QSRC Supervisor/Manager absence, serve as initial contact for QSRC issues.
12. Educate Arthrex Organization on QSR’s and ISO standards.
13. Support the QSRC Department with respect to evaluations, investigations, and implementations of QMS items w ith primary focus on the CAPA process.
14. Implement QSRC improvements and supports ongoing continuous improvement efforts with primary focus on the CAPA process.
     
    Incidental Duties:

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.

5 years experience in an FDA /ISO regulated environment required.

Previous project leadership experience preferred.

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.