Quality Systems Lead - ISO & Audit Champion

Professions-Inc; South Bend (IN); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Professions-Inc is seeking a Quality Systems & Compliance Lead in Northwest Indiana to own the QMS in a hands-on manufacturing environment. You will drive ISO 9001, 13485, and 14001 compliance, lead audits, and translate regulatory requirements into practical floor-level processes across medical and industrial operations.

This senior individual contributor role requires cross-functional influence, CAPA ownership, and strong documentation governance to ensure audit readiness and continuous

Qualifications

• 7+ years in Quality Systems, Quality Engineering, or Manufacturing Quality.

Responsabilités

• Own and maintain the QMS within an electronic QMS platform.
• Ensure ISO 9001, 13485 and 14001 compliance.
• Develop, implement and maintain internal audit program.
• Conduct internal audits and close findings.
• Lead ISO certification audits and support customer audits.
• Translate regulatory requirements into practical manufacturing processes.
• Identify gaps and drive system-level improvements.
• Own CAPA process with root-cause analysis and actions.
• Monitor CAPA timelines and effectiveness.
• Oversee document control governance and training alignment.
• Support cross-functional teams on document creation and compliance.
• Standardize quality processes across medical and industrial manufacturing.
• Ensure audit readiness across all departments.

Connaissances

Regulatory translation

Root cause analysis

Project management

Independence

Cross-functional communication

Influence without authority

Detail oriented

Formation

Bachelor’s degree in Engineering/Quality/Manufacturing

ISO Lead Auditor / ASQ CQE / CQA certification

Outils

eQMS

1factory

Description du poste

Professions-Inc is seeking a Quality Systems & Compliance Lead in Northwest Indiana to own the QMS in a hands-on manufacturing environment. You will drive ISO 9001, 13485, and 14001 compliance, lead audits, and translate regulatory requirements into practical floor-level processes across medical and industrial operations.

This senior individual contributor role requires cross-functional influence, CAPA ownership, and strong documentation governance to ensure audit readiness and continuous