Sr Quality Systems Spec - Exempt

Job Description

Job Description

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

• Bachelor’s 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.

#ZR

Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.

Company Description

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.