QA Manager - Multi-Site Manufacturing & QMS Lead

Talnt

Akron (OH)

Sur place

USD 95 000 - 135 000

Plein temps

Il y a 7 jours
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Résumé du poste

Talnt is seeking an experienced QA Manager to lead QA programs, regulatory compliance, and QMS across multiple manufacturing facilities in Ohio. You will drive CAPA, audits, and documentation control while collaborating with QC, Manufacturing, Compliance, and R&D to ensure product quality and regulatory readiness.

The role requires a Bachelor's in a technical field, 5+ years in QA/QMS in manufacturing, strong leadership, and knowledge of GMP and continuous improvement methods; experience with

Qualifications

  • Bachelor's degree or equivalent in a technical discipline with manufacturing quality experience.
  • 5+ years of progressive QA/quality systems experience in manufacturing.
  • Experience leading QA operations and maintaining QMS across multiple sites.
  • Strong knowledge of GMP, SOPs, QC practices, and controlled documentation.
  • Hands-on with internal audits, nonconformances, root cause analysis, and CAPA.
  • Experience collaborating with QC, Manufacturing, R&D, and Compliance to resolve quality issues.
  • Proven leadership and communication skills for cross-functional teams and senior management.

Responsabilités

  • Lead QA programs across multiple manufacturing facilities, ensuring quality policies and regulatory requirements are followed.
  • Develop, implement, and continuously improve QMS, SOPs, manuals, and manufacturing documentation.
  • Oversee internal audits, compliance assessments, and process evaluations to identify risks and improvements.
  • Manage CAPA processes including root cause analysis and effectiveness verification.
  • Coordinate with QC to align QA systems with inspections, testing, and specs.
  • Lead quality improvement initiatives to reduce defects and strengthen process reliability.
  • Maintain audit readiness and accurate quality records with traceability.

Connaissances

Leadership
Cross-functional collaboration
Quality assurance
Regulatory compliance
CAPA
Documentation
GMP
Audits
Root cause analysis
Problem-solving

Formation

Bachelor's degree in Quality Management, Engineering, Manufacturing, Industrial Technology, Chemistry, or related field
CMQ/OE or CQE preferred

Outils

eQMS
ERP platforms
Document control software
Quality reporting tools

Description du poste

Talnt is seeking an experienced QA Manager to lead QA programs, regulatory compliance, and QMS across multiple manufacturing facilities in Ohio. You will drive CAPA, audits, and documentation control while collaborating with QC, Manufacturing, Compliance, and R&D to ensure product quality and regulatory readiness.

The role requires a Bachelor's in a technical field, 5+ years in QA/QMS in manufacturing, strong leadership, and knowledge of GMP and continuous improvement methods; experience with

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