Quality Control Manager - Lead ISO, FDA & CAPA

Local Sales Network, LLP; Sparta (TN); Hybrid; USD 85,000 - 135,000; Full time

Job summary

Express Employment Professionals in Sparta, TN, seeks an experienced Quality Manager to lead QA activities across manufacturing. You will ensure compliance with ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP, and drive continuous improvement.

You will oversee quality control, audits, CAPA, PPAP support, and collaboration with HQ and customer teams to resolve issues and enhance product quality. This role emphasizes hands-on leadership and process optimization.

Qualifications

• Proven leadership experience in quality within manufacturing.
• Strong knowledge of ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP.
• Hands-on audits, inspections, root cause analysis, and CAPA.

Responsibilities

• Oversee product quality and provide weekly summaries to HQ and site leadership.
• Identify non-conforming materials and lead corrective action reports (8D) and CAPA activities.
• Conduct inspections of products and raw materials; manage daily quality control processes.
• Coordinate with customer quality teams and HQ to resolve quality concerns.
• Support PPAP requirements, including documentation and reliability testing.
• Prepare for and participate in customer audits and IATF 16949 certification audits.
• Develop and maintain quality programs aligned with regulatory standards.
• Lead internal and external audits and ensure compliance with policies and regulations.
• Analyze quality data to identify trends and opportunities for improvement.
• Maintain quality documentation, procedures, and validation records.
• Collaborate with cross-functional teams to resolve issues and improve product quality.
• Train staff on quality systems, inspection practices, and regulatory compliance.

Skills

Quality management

ISO 13485

ISO 9001

FDA regulations

CAPA

Quality audits

Job description

Express Employment Professionals in Sparta, TN, seeks an experienced Quality Manager to lead QA activities across manufacturing. You will ensure compliance with ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP, and drive continuous improvement.

You will oversee quality control, audits, CAPA, PPAP support, and collaboration with HQ and customer teams to resolve issues and enhance product quality. This role emphasizes hands-on leadership and process optimization.