Manager of Quality - Complaints and Deviations

Sartorius Stedim Filters, Inc.; Yauco (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid vacation and sick leave

14 paid holidays annually

Medical, Dental and Vision insurance

Company Retirement Plan

On-site cafeteria and coffee shop

On-site occupational health offices

Job summary

Sartorius is seeking a Manager of Complaints and Deviations to lead end-to-end handling of customer complaints and quality deviations at our site. You will investigate issues, drive CAPAs, and ensure compliance with ISO standards and regulatory requirements while coordinating with cross-functional teams.

The role emphasizes data-driven improvement, KPI reporting, and collaboration with global sites to maintain top product quality and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• Minimum of 5 years of experience in Quality Management, including leadership roles.
• Certification and working knowledge of ISO 9001, ISO 13485 is a strong advantage.
• Strong proficiency in precision measuring tools and statistical analysis methods.
• In-depth understanding of quality assurance procedures and regulatory standards.

Responsibilities

• Oversee intake, assessment, investigation, and closure of customer complaints for timely resolution.
• Manage identification, classification, and investigation of deviations from manufacturing, laboratory, and operational activities.
• Lead cross-functional teams in root cause analyses to determine drivers of quality issues.
• Initiate, track, and close CAPAs linked to complaints and deviations.
• Ensure compliance with regulatory requirements and internal quality standards.
• Monitor trends in complaints/deviations to identify recurring issues and support data-driven decisions.
• Collaborate with global and local teams to align processes and share best practices.
• Define, track, and report KPIs related to complaints and deviations.
• Engage with manufacturing, quality, and customer-facing teams to resolve issues.
• Support audits by providing documentation and addressing observations.
• Drive continuous improvement initiatives to enhance processes.
• Provide training and guidance on procedures, systems, and best practices.

Education

Bachelor's degree in Engineering/Science

Tools

Minitab

SAP

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Test analysis software

Job description

The Manager of Complaints and Deviations

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

Equal Employment Opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans. Please view equal employment opportunity posters provided by OFCCP here.

E-Verify Participation

E-Verify Participation Info E-Verify Workers Rights About Sartorius

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution.