Quality & Compliance Auditor

Position Overview

We are seeking a Quality & Compliance Auditor to play a key role in maintaining and enhancing the Quality Management System (QMS) at Sartorius’ Yauco facility. This professional will lead and participate in internal audits, ensuring compliance with ISO standards (9001 and/or 13485) and other applicable regulatory requirements. Responsibilities will span document review, audit execution, risk-based analysis, and formal reporting of findings.

 

The ideal candidate brings strong auditing experience, proven ISO certification credentials, and working knowledge across various quality subsystems such as CAPA, Investigations, Supplier Quality, Complaints Handling, Risk Management, and Validation/CSV.

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Scope & Responsibilities

• Serve as ISO Lead Auditor (ISO 9001 and/or ISO 13485 certification strongly preferred).
• Conduct internal audits within the Quality Management System to assess compliance and identify improvement opportunities.
• Maintain strong expertise in quality and compliance systems in regulated environments, including familiarity with GMP guidelines.
• Support and assess key processes such as:
  • Supplier Quality Management
  • Corrective and Preventive Actions (CAPA)
  • Investigations and Complaints Handling
  • Management Review
  • Risk Management
  • Validation / Computer System Validation (CSV)
• Collaborate with cross-functional teams—including Quality, Manufacturing, Engineering, and Supply Chain—to ensure procedural compliance and drive continuous improvement.
• Document findings and deliver audit reports outlining observations, non-conformances, and recommendations for corrective actions.

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Qualifications

• Certified as an ISO Lead Auditor for ISO 9001 or ISO 13485.
• Demonstrated experience as an Internal Auditor in a regulated (e.g., pharmaceutical, biotech, or medical devices) environment.
• Solid background in Quality & Compliance, particularly in ISO-driven systems.
• Familiarity with: supplier quality, CAPA, investigations, management review, complaints, risk management, validation/CSV.
• Strong analytical skills, attention to detail, and ability to communicate effectively in English.

**Weil Group is proud to be an Equal Employment Opportunity Employer.*