Posted in General Business about 7 hours ago.
Type: Full-Time
Requisition ID: 61298 Title: Quality Systems Analyst I Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, 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 Analyst I who will support the Quality Systems Department to maintain and improve the Arthrex global Quality Management System (QMS), in compliance with FDA QSR, ISO 13485, MDSAP, and all other applicable regulatory requirements. The Quality System Specialist role may provide focused support for one or more Quality System area, including Document/Records Management, CAPA, NCR, Auditing, or Change Management. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Sign-on Bonus: A one-time sign-on bonus of $2,000.00 minus appropriate tax withholding will be paid to you on the first pay period after you start your employment at Arthrex.
Essential Duties and Responsibilities:
Education and Experience:
High School Diploma or equivalent required.
Previous experience working in a regulated or manufacturing industry and in support of a Quality Management System is preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Possesses a limited knowledge of Good Documentation Practices (GDP) as required by regulatory and quality standards.
Knowledge of administrative procedures and computer systems such as word processing, managing files and records, Excel, Power Point, Documentum, SAP, and Microsoft Outlook.
Basic understanding of QMS software as defined in Arthrex QMS policies and procedures
Reasoning Ability:
Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mathematical Skills:
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 30 pounds.
Vision Requirements:
Visual acuity necessary to do the job safely and effectively. Specific vision abilities required by this job include close vision.
Work Environment:
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles. The noise level in the work environment is usually moderate.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Requires frequently working in clean room and controlled environment utilizing specified cleaning agents. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Arthrex Benefits
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
Arthrex Manufacturing, Inc. |
Arthrex Manufacturing, Inc. |