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 QA Global Alignment Specialist II for our Global Headquarters in Naples, FL. The Specialist II, Global Alignment will advance Arthrex’s Mission and Quality Policy by leading initiatives focused on continuously improving Quality systems anchored in the Corporate QMS and applied appropriately for regional compliance and functional excellence. The Specialist, QA Global Alignment will partner with Regional constituents to collaboratively achieve the following objectives for Quality Assurance:

• Global reach, consistency, communication
• Assessment and alignment of legacy constructs
• Compliance with applicable external and internal standards
• Continuous Improvement
• Continued suitability, adequacy, and effectiveness of the Arthrex Quality System.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Advance the continued forward motion of Arthrex Global business by driving traceability, consistency, and transparency worldwide.
• Develop the structure for the evolving quality responsibilities in the business relationships between Arthrex, Inc. and its global subsidiaries.
• Partner with Local and Regional Constituents to:
• Perform Baseline Assessments of Quality Management Systems
• Identify Risks to Regional Compliance and Global Alignment
• Develop Gap Closure Plans
• Manage the Execution of those Plans
• Promote Continuous Improvement
• Ensure appropriate change management practices for globally aligned subsidiaries, distributors, and other business partners including:
• Communication Planning
• Holistic Risk Impact Assessment
• Cross-Functional Implementation Plans
• Computer System Support
• Process and Procedure Improvement
• Training Development and Delivery
• Effectiveness Management
• Metrics Development and Reporting
• Arrange for corporate support of such objectives through the Quality Management System Element Owners, Master Data Governance, and any other relevant systems.
• Implement strategic, repeatable methods for implementing aligned systems and processes at subsidiaries.
• Facilitate kaizen, problem-solving, and rapid process improvement events with global associates with a major emphasis on focused, measurable improvement.
• Apply Lean and Six Sigma methodologies in the implementation of process excellence initiatives.
• Drive the standardization of process, where appropriate, while recognizing where flexibility is necessary for regional compliance.
• Help facilitate, with interdepartmental managers, the availability, assignment, and accountability of downstream resources and technology for projects.

Education and Experience:

• Bachelor’s degree required in business administration or science
• 2 years of experience working in a FDA Regulated industry required
• Experience managing complex projects required
• Experience working with global teams preferred

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

Reasoning Ability:

Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn, understanding the implications of new information for both current and future problem-solving and decision-making.

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.

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.