Quality Systems Specialist I: QMS & Compliance

Oxford Global Resources; Milwaukee (WI); On-site; USD 87,000 - 114,000; Full time

Benefits offered by this job

Medical benefits

401(k) Retirement Savings Plan

Paid holidays and paid sick leave

Job summary

Oxford Global Resources is seeking a Quality Compliance professional to support the global Quality Management System, ensure alignment with FDA QSR and ISO standards, and assist in documentation, CAPAs, NCRs, and continuous improvement activities.

The role focuses on audit support, change control, document management (EDMS), and regulatory compliance across QA, Regulatory Affairs, R&D and Operations, with site-based collaboration in Tucson and ongoing process enhancements.

Qualifications

• 3 years related experience in a regulated industry; 5 years preferred
• Experience in medical devices or other regulated industry preferred
• Experience in Change Management, Inspection and CAPA Management is an added advantage
• Exposure to internal, external, laboratory, supplier auditing programs as appropriate

Responsibilities

• Support compliance, maintenance and improvement of the global quality management system
• Assist in audit preparation efforts for the site in Tucson, AZ
• Support generation of QMS documentation using EDMS
• Maintain document/record retention aligned with corporate requirements
• Create and monitor CAPAs and NCRs; assist in periodic reviews of Quality System
• Provide training support in quality concepts and tools
• Drive continuous improvement of quality processes
• Support review of policies and procedures to ensure regulatory compliance

Skills

Change Management

CAPA Management

Audit programs

Regulatory compliance

Tools

EDMS

Job description

Oxford Global Resources is seeking a Quality Compliance professional to support the global Quality Management System, ensure alignment with FDA QSR and ISO standards, and assist in documentation, CAPAs, NCRs, and continuous improvement activities.

The role focuses on audit support, change control, document management (EDMS), and regulatory compliance across QA, Regulatory Affairs, R&D and Operations, with site-based collaboration in Tucson and ongoing process enhancements.