Sr Quality Systems Spec Exempt

Brooklyn Center, MN - USA

Monthly Salary: Not Disclosed

Posted on: 14 days ago

Vacancies: 1 Vacancy

Job Summary

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

Bachelors Degree with a minimum of 5 years of relevant experience or advanced degree with at least 3 years of experience.
Experience within a medical device pharmaceutical or regulated environment.
Experience managing large-scale cross-functional projects.
Strong knowledge of Quality System Management principles.
Proficient in Microsoft Office applications.

Preferred / Nice to Have

Lean / Six Sigma certification.
Project management and risk mitigation experience.
Prior involvement in acquisitions or mergers.
Deep understanding of FDA 21 CFR Part 820 Part 11 and ISO 13485 standards.
Familiarity with PLM systems (Agile Windchill).
Strong analytical process improvement and decision-making skills.
Proven ability to mentor junior professionals and manage complex quality initiatives.

Knowledge & Experience Level

Advanced professional expertise combining both breadth and depth of QMS understanding.
Works independently under limited supervision managing end-to-end project execution.
Provides guidance coaching and training to other quality professionals.
Communicates with senior leadership and external stakeholders to influence decisions and ensure compliance excellence.

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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 Quali...