Senior Quality Systems & Compliance Leader

Professions Inc; South Bend (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

Professions Inc in Northwest Indiana is seeking a Quality Systems & Compliance Lead to own and maintain the QMS across a hands-on manufacturing environment, ensuring ISO 9001, 13485, and 14001 compliance while driving practical quality processes on the shop floor.

This senior individual contributor role leads internal and external audits, champions CAPA and document control, partners with Operations and Engineering, and builds standardized quality system practices across medical and industrial

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related field preferred.
• Relevant certifications such as ISO Lead Auditor, ASQ CQE, or CQA preferred.

Responsibilities

• Own and maintain the Quality Management System (QMS) within an electronic QMS platform.
• Ensure compliance with ISO 9001, ISO 13485, and ISO 14001 requirements.

Skills

Regulatory translation

Cross-functional communication

Project management

Influence without authority

Systems thinking

Education

Bachelor’s degree (Engineering/Quality/Manufacturing)

ISO Lead Auditor / CQE / CQA certifications

Tools

eQMS systems

1factory or similar platform

Job description

Professions Inc in Northwest Indiana is seeking a Quality Systems & Compliance Lead to own and maintain the QMS across a hands-on manufacturing environment, ensuring ISO 9001, 13485, and 14001 compliance while driving practical quality processes on the shop floor.

This senior individual contributor role leads internal and external audits, champions CAPA and document control, partners with Operations and Engineering, and builds standardized quality system practices across medical and industrial