The Manager of Complaints and Deviations is responsible for overseeing the end-to-end management of Product complaints and quality deviations. The role ensures that all issues are investigated, documented, and resolved in compliance with applicable regulatory requirements and internal quality standards. This position collaborates cross-functionally to drive continuous improvement, maintain product quality, and support customer satisfaction.
Grow with Us - Your Responsibilities
Oversees the intake, assessment, investigation, and closure of customer complaints to ensure timely and compliant resolution
Manages the identification, classification, and investigation of deviations arising from manufacturing, laboratory, and operational activities
Leads cross-functional teams in conducting root cause analyses to determine underlying drivers of quality issues
Ensures the effective initiation, tracking, and closure of corrective and preventive actions (CAPAs) linked to complaints and deviations
Maintains compliance with applicable regulatory requirements and internal quality standards across all complaint and deviation processes
Monitors and analyzes trends in complaints and deviations to identify recurring issues and support data-driven decision-making
Collaborates with global and local teams to align processes, share best practices, and ensure consistency across sites
Defines, tracks, and reports key performance indicators (KPIs) related to complaints and deviations to monitor performance and drive accountability
Engages with internal stakeholders, including manufacturing, quality, and customer-facing teams, to ensure effective issue resolution
Supports internal and external audits by providing documentation, responding to inquiries, and addressing observations related to quality events
Drives continuous improvement initiatives to enhance the efficiency and effectiveness of complaint and deviation management processes
Provides training and ongoing guidance to personnel on procedures, systems, and best practices related to complaints and deviations
What Will Convince Us
Bachelor’s degree in Engineering, Science, or a related field
Minimum of 5 years of experience in Quality Management, including roles such as Supervisor, Manager, or other leadership positions
Certification and working knowledge of ISO 9001, ISO 13485, and regulated environments is considered a strong advantage
Strong proficiency in precision measuring tools and statistical analysis methods
In-depth understanding of quality assurance procedures and applicable regulatory standards
Knowledge of regulatory requirements related to customer complaints and customer observations
Solid understanding of Quality Management Systems (QMS) and associated management processes
Advanced expertise in root cause analysis, investigations, change control, and CAPA management
Excellent analytical thinking, problem-solving, and decision-making capabilities
Effective communication, presentation, organizational, and leadership skills
Experience in staff relations and team management
Strong teamwork orientation, adaptability, and change management skills
Ability to collaborate effectively with global and cross-functional teams in support of site and organizational objectives
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook), Minitab, SAP, and computerized test analysis systems
Fully bilingual in Spanish and English
What We Offer
Paid vacation and sick leave
14 paid holidays annually
Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees.
We offer conference areas, and a development center
Medical, Dental and Vision insurance along with Company Retirement Plan
On-site cafeteria and coffee shop
On-site occupational health offices including Laboratory Services
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity…