ISO 17025 Quality Manager — Dual-Lab Compliance & Improvement

Phigenics, LLC; Warrenville (IL); Vor Ort; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Phigenics, LLC seeks a PASL Quality Manager to own and improve the QMS for Warrenville and Fayetteville labs. Lead audits, CAPA, and management reviews to ensure accreditation conformity and regulatory alignment.

The role requires 5+ years in laboratory quality with ISO/IEC 17025 expertise, and strong documentation and leadership skills to mentor the quality team and maintain data integrity across systems.

Qualifikationen

• Bachelor's degree in a scientific field and 5+ years quality experience in ISO/IEC 17025 labs.
• Experience leading internal and external audits, CAPA, and management reviews.
• Knowledge of measurement uncertainty, method validation/verification, and proficiency testing.

Aufgaben

• Own and improve the PASL Quality Management System per ISO/IEC 17025 and standards.
• Serve as primary contact with accrediting bodies for audits.
• Plan and execute internal audits; support external accreditation audits.

Kenntnisse

Quality leadership

Audit management

CAPA process

Documentation control

Policy & procedure development

Strong communication

Ausbildung

Bachelor's degree in Chemistry, Microbiology, Biology

ISO/IEC 17025 Internal Auditor or Lead Assessor training preferred

ASQ Certified Quality Auditor (CQA) or similar credential a plus

Hands-on QA/QMS experience in ISO/IEC 17025 labs

Tools

ATL Titan LIMS

Bio-Rad CFX Manager

EndoScan-V

FedEx Ship Manager

MS Office

Jobbeschreibung

Phigenics, LLC seeks a PASL Quality Manager to own and improve the QMS for Warrenville and Fayetteville labs. Lead audits, CAPA, and management reviews to ensure accreditation conformity and regulatory alignment.

The role requires 5+ years in laboratory quality with ISO/IEC 17025 expertise, and strong documentation and leadership skills to mentor the quality team and maintain data integrity across systems.