Sr Quality Systems Spec Exempt

Job Title : Quality Systems Specialist

Client : Medical Device Manufacturing Company

Duration : 12 Months (Possible Extension)

Location : Brooklyn Center MN 55430

Shift : 1st Shift 100% On-site

Role Overview

The Sr. Quality Systems Specialist will be responsible for overseeing and integrating Quality Management System (QMS) processes across multiple locations. This role ensures compliance with FDA and ISO standards while driving continuous improvement in quality systems and cross-functional collaboration.

Key Responsibilities

• Support integration of QMS processes across sites and departments.
• Evaluate and align interactions between QMS elements across Development Operations Quality and Supply Chain.
• Review and update QMS documentation including procedures manuals plans and agreements.
• Coordinate training requirements and ensure compliance readiness.
• Provide oversight for quality programs and ensure adherence to internal and regulatory standards.
• Lead or support audit and inspection readiness corrective actions and compliance reporting.
• Work closely with functional leaders to identify process improvements and standardize best practices.
• Act as a subject matter expert on regulatory compliance (FDA 21 CFR 820 ISO 13485).

Required Qualifications

Preferred / Nice to Have

Knowledge & Experience Level

#ZR

Key Skills

Computer Science,Active Directory,Computer information Technology,PowerShell,OS,Windows,Database,SCCM,Linux,SAN,Troubleshoot,Backup,Setup,Technical Support,UNIX

Employment Type : Full Time

Experience : years

Vacancy : 1