Manager of Quality - Complaints and Deviations
Sartorius Stedim•Yauco, PR
About The Position
The Manager of Complaints and Deviations oversees the end-to-end management of product complaints and quality deviations. This role ensures issues are investigated, documented, and resolved in compliance with applicable regulatory requirements and internal quality standards. Working with global, local, and cross-functional teams, the manager supports continuous improvement, product quality, and customer satisfaction.
Requirements
- Bachelor’s degree in Engineering, Science, or a related field.
- At least 5 years of experience in Quality Management, including experience in a leadership position such as Supervisor or Manager.
- Strong proficiency with 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.
- Full bilingual proficiency in Spanish and English.
Nice To Haves
- Certification and working knowledge of ISO 9001, ISO 13485, and regulated environments.
Responsibilities
- Oversee intake, assessment, investigation, and closure of customer complaints to ensure timely and compliant resolution.
- Manage identification, classification, and investigation of deviations arising from manufacturing, laboratory, and operational activities.
- Lead cross-functional root cause analyses to determine the underlying drivers of quality issues.
- Ensure effective initiation, tracking, and closure of corrective and preventive actions (CAPAs) linked to complaints and deviations.
- Maintain compliance with applicable regulatory requirements and internal quality standards across complaint and deviation processes.
- Monitor and analyze complaint and deviation trends to identify recurring issues and support data-driven decision-making.
- Collaborate with global and local teams to align processes, share best practices, and ensure consistency across sites.
- Define, track, and report key performance indicators (KPIs) related to complaints and deviations.
- Engage internal stakeholders, including manufacturing, quality, and customer-facing teams, to support effective issue resolution.
- Support internal and external audits by providing documentation, responding to inquiries, and addressing observations related to quality events.
- Drive continuous improvement initiatives to enhance complaint and deviation management processes.
- Provide training and ongoing guidance to personnel on related procedures, systems, and best practices.
Benefits
- Paid vacation and sick leave.
- 14 paid holidays annually.
- Campus with conference areas and a development center.
- Medical, dental, and vision insurance.
- Company retirement plan.
- On-site cafeteria and coffee shop.
- On-site occupational health offices, including laboratory services.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
