Supervisor Global CAPA

Requisition ID: 59684  Title: Supervisor Global CAPA  Division: Arthrex, Inc. (US01)  Location: Naples, 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 Supervisor, Global CAPA who will lead the Arthrex CAPA Quality program, developing and implementing global CAPA policy, strategy, systems, and efficiency tools. The Supervisor Global CAPA will be an advocate for multi-site collaboration, continuous improvement, process standardization, and compliance; driving world class results with the goal of continually improving quality system CAPA and NC process performance. 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 CAPA Process Owner and Champion across the organization.
• Transform CAPA processes to be world class by developing and implementing industry leading principles, strategies, plans, tactics, methods and tools.
• Translate best-in-class CAPA Quality initiatives into actionable global policies, systems and standard operating procedures that lead to an improved operational performance.
• Assess and provide a clear vision of CAPA excellence across the business driving collaboration, strategy, direction, management, and oversight of the global CAPA program.
• Recommend optimization of CAPA related electronic support systems.
• Collaborate and partner with cross functional stakeholders to develop a network of CAPA leaders and CAPA process advocates.
• Responsible to ensure that the global CAPA 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, and the EUMDR as applicable.
• Chair the CAPA review board and ensures that CAPAs managed meet or exceed all metrics / goals.
• Define the process to identify, trend, and escalate complex quality and compliance issues so that they can be effectively resolved; assess their impact across the business and identify potential areas of vulnerabilities.
• Provide oversight and training for direct reports and cross functional peers / subordinates to manage CAPA. Support direct reports in gaining knowledge of all applicable standards, regulations, Arthrex policies, procedures, and work instructions, as per an individual development plan.
• Provide strategic oversight to the CAPA programs at each site location, helping to ensure site resources who manage CAPA have appropriate skills and qualifications.
• Responsible for developing CAPA training content and ensuring training is robustly implemented and iterated.
• Ensure global CAPA program health by providing metrics and reporting to business leaders.
• Responsible for collection, production and publication of compliance data related to CAPA.
• Interface with all sites and site stakeholders for technical assistance and problem solving in areas of CAPA.
• Present to FDA, Notified Body, and / or senior executive leadership on the overall status and performance of the CAPA process.

 

 

Education and Experience:

• Bachelor's degree required, preferably in engineering or science.
• 5 years’ experience in Quality Assurance, and or Lean Six Sigma required.
• 2 years’ experience as a people leader preferred.  
• 1 years’ expertise with Corrective Action and Preventative Action and Root Cause problem solving methodology including 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 levels within the organization up to the senior management level is required.

 

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 English language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbal