Manager, Quality Systems Auditing

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 Manager of Quality Systems Auditing who will lead the Arthrex Internal Auditing program. The Manager of Quality Systems Auditing is responsible for developing and implementing global Internal Auditing policy, strategy, systems, and efficiency tools. The Manager of Quality Systems Auditing will advocate for multi-site collaboration, continuous improvement, process standardization, and compliance, driving world-class results to continually improve the Arthrex, Inc. Quality Management System. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Assume the role of QMS Audit Process Owner and Champion across the organization.
• Assess and provide a clear vision of Internal Audit excellence across the business, driving collaboration, strategy, direction, management, and oversight of the global Internal Audit program.
• Recommend optimization of Internal Audit-related electronic support systems.
• Ensure that the Internal Audit program meets all applicable requirements and regulations, including but not limited to FDA 21 CFR Part 820, ISO 13485:2016, MDSAP, and Regulation EU 2017/745 as applicable.
• Collaborate with Quality Management to identify, trend, and escalate complex quality and compliance issues so they can be effectively resolved; assess their impact across the business and identify potential vulnerabilities.
• Provide oversight and training for direct reports and cross-functional peers/subordinates to manage Internal Audits. Support direct reports in gaining knowledge of all applicable standards, regulations, Arthrex policies, procedures, and work instructions per an individual development plan.
• Provide strategic oversight to the Internal Audit programs at each site location, helping to ensure site resources who manage Internal Audits have appropriate skills and qualifications.
• Responsible for developing Internal Audit training content and ensuring training is robustly implemented and iterated.
• Ensure global Internal Audit program health by providing metrics and reporting to business leaders.
• Responsible for collecting, producing, and publishing compliance data related to Internal Audits.
• Interface with all sites and site stakeholders for technical assistance and problem-solving in areas of Internal Audits.
• Present to the FDA, Notified Body, and/or senior executive leadership on the overall status and performance of the Internal Audit process.

Education and Experience:

• Bachelor's degree required, preferably in engineering or science field.
• Six years’ experience in Quality Assurance required.
• Three years’ expertise with Quality Management System auditing, including team-leading and extensive experience leading transformational change initiatives in a dynamic environment required.

Knowledge and Skill Requirements/Specialized Courses and/or Training: 

• Strong written and verbal communication skills are required, along with robust presentation skills.
• Ability to work comfortably at all organizational levels up to the senior management level is required.
• Knowledge of statistical processes and trending.
• Certified Quality Auditor.

Machine, Tools, and/or Equipment Skills:

Use of typical office equipment. Proficient with Microsoft Office programs.

Reasoning Ability:

Ability to define problems, collect 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.

Arthrex 2024 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)
• Eligible for discretionary Long Term Incentive program

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.