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 Manager - LATAM who is responsible for all Quality-related activities for LATAM including; Quality Management System (QMS) and coordination of daily quality activities in the region, maintaining understanding and compliance with Corporate quality requirements affecting Regional company operations and products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
This is an onsite position in Naples, Florida - relocation assistance is provided.
Essential Duties and Responsibilities:
Lead and manage the Quality Assurance teams located at various subsidiaries across Latin America.
Develop, implement, and maintain quality assurance policies and procedures that conform to international standards, including ISO 13485.
Oversee the management of audits (both internal and external), including preparation, corrective action plans, and follow-up.
Monitor and evaluate the effectiveness of CAPAs to ensure continuous quality improvements and compliance with regulatory standards.
Lead and manage post-market regulatory activities such as complaint management, field actions, and adverse event reporting across Latin America.
Drive continuous improvement initiatives across the subsidiaries, focusing on quality control and assurance processes.
Ensure effective communication and training on quality standards and compliance is delivered across all levels of the organization.
Establishes and/or maintains document management systems for regional document control ensuring accuracy and completeness as well as document security.
Manage cross-functional relationships across the organization to drive continuous improvement of the QMS and related processes.
Report regularly to Management on quality metrics, risks, and overall performance of the quality management system.
Collaborate with Regulatory Affairs to ensure all products meet the local requirements for each country within Latin America.
Support Arthrex Global Initiatives as appropriate.
Education and Experience:
Bachelor's Degree required, preferably in a Science or Engineering discipline.
7+ years of direct experience in the administration of quality system elements within a medical device organization within the LATAM market
Fluency in English and Spanish is required, proficiency in Portuguese is preferred
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge and a clear understanding of FDA and ISO, regional regulations in the areas of Quality System Requirements including topics such as CAPA, Auditing, and Document Control.
Knowledge of medical device products and distribution in the Regulated environment, especially in LATAM countries.
High Degree of experience in understanding of quality control practices, standards, and principles.
High Degree of experience in understanding regulations in LATAM countries, especially Brazil, MDSAP members, and ISO guidelines for medical devices required.
Excellent and proven interpersonal skills.
Strong interpersonal, English oral, and written communication skills required.
Strong project management skills
Ability to work in fast paced environment and handle multiple tasks and requests.
Comprehension of orthopedic technical/engineering/medical terminology, or can reference literature for understanding.
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools. MS Office skills, Pilgrim SmartSolve, SAP or similar inventory software as well as CAPA, NCR, Audit or Complaint Management software.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
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.
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, protected veteran status, or any other status protected by law.
