Quality Systems Analyst I

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:

• Supports, organizes and coordinates ongoing projects in Quality Systems to assure the Arthrex QMS meets all applicable requirements.
• Supports the various Quality System superuser network(s) for the site through coordination of Quality System processes (Document Management, Change Management, CAPA, etc).
• Provide guidance to users of QMS software regarding use and regulatory and compliance requirements.
• Supports Quality Systems training activities for new and current employees.
• Assists business/process owners with the development, revision and review of QMS documents for compliance and completeness.
• Supports and/or performs Quality Systems data trending to assure applicable requirements and management goals are being met.
• Supports Product Surveillance activities based on business priorities and departmental workload.
• May support site Internal Audit program through completion of the Arthrex qualified QMS auditor process for associate and/or lead auditor.
• May support External Audit program through audit preparation, handling of documentation requests, backroom and front room support.

Quality System-specific tasks may include:

• Document management activities may include: processing document transactions through the electronic document management system, site record management, training of users on system functionality, record scanning and filing. Higher level roles may serve as system SME, providing higher level oversight and input into system design and operation.
• Change Management activities may include: processing change record transactions in the electronic system, reporting on activity status and timeliness, follow up with record owners, training of users on system functionality, review of Change Management plans and records to ensure compliance. Higher level roles may serve as system SME, providing higher level oversight and inputs regarding regulatory expectations, and providing input into systems design and operation.
• Audit management activities may include: support of internal audit program through scheduling of audits, entry and management of internal audit findings, reporting on activity status and timeliness. External audit support may include backroom set up and record retrieval during audits. In some cases, Quality System Analysts may be trained to execute audits.

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

• 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)

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.