Quality & Compliance Auditor
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Job Summary
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.
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 teamsincluding Quality Manufacturing Engineering and Supply Chainto ensure procedural compliance and drive continuous improvement.
- Document findings and deliver audit reports outlining observations non-conformances and recommendations for corrective actions.
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.
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- ISO 9001
- Quality Audits
- Process Mapping
- Fair Housing Regulations
- Quality Control
- Underwriting
- cGMP
- As9100
- Manufacturing
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