Back to Jobs search

Quality Management Systems Specialist

System One • Cary, IL • 7h ago

Job Title: Quality Management Systems Specialist

Location: Cary, Illinois

Type: Contract

Compensation: $50-55/hr

Work Model: Hybrid - onsite and remote

Overview

Join a global medical technology organization undergoing an exciting quality systems integration initiative. This hybrid contract opportunity offers the chance to lead critical Change Control activities, collaborate with international stakeholders, and drive process improvements within a highly regulated environment. Ideal for an experienced QMS professional who thrives on cross-functional collaboration, compliance excellence, and making a measurable impact on organizational quality and regulatory success.

Responsibilities

Support QMS integration activities by leading and owning the Change Control process within a regulated medical device environment

Ensure all changes are appropriately documented, assessed for impact, and effectively implemented in compliance with quality and regulatory requirements

Mentor cross-functional stakeholders on proper change execution and support the integration of quality system processes across the organization

Own and manage the Change Control process to ensure compliance, consistency, and effectiveness

Review and approve change records for completeness, accuracy, and impact assessments

Ensure changes are implemented correctly, including verification of downstream activities such as documentation updates, training, and record retention

Drive process improvements and standardization to support integration efforts

Evaluate process gaps and define scalable, compliant solutions

Collaborate with teams in Germany to align change activities with timelines and business needs, demonstrating flexibility with CET/CEST hours

Develop and revise quality system documentation including procedures, work instructions, and change records

Partner with Quality, Regulatory, R&D, and Operations teams to ensure alignment on changes and integrations

Act as a quality representative during project discussions and integration activities

Communicate progress, risks, and recommendations to stakeholders

Requirements

Bachelor's degree in engineering, science, or a related field

5+ years of experience in a regulated environment, preferably in medical devices

Proven expertise in Change Control processes and quality system integration or harmonization

Strong knowledge of Quality Management Systems (QMS) and applicable regulatory standards such as FDA, ISO 13485, EU MDR

Deep understanding of interactions between Change Control, Document Control, Training, and Records processes

Excellent technical writing and documentation skills

Strong organizational, problem-solving, and project coordination abilities

Ability to influence, mentor, and drive process consistency across teams

Proficiency in Microsoft Word, Excel, PowerPoint, Teams, and SharePoint

Preferred German language proficiency (written and verbal)

Ability to work flexible hours accommodating German time zones

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

Similar Jobs

VICE PRESIDENT OF HUMAN RESOURCES OPERATIONS

Little City Foundation • Inverness, IL • 1d ago

Management & Administrative

Salary Range $95,000.00 - $100,000.00 Salary/year Position Type Full Time Job Shift Business Hours Education Level Bachelor's Deg| Masters PREF| 10 YRS EXP Category Health Care Description HOW TO APPLY: Visit : www.littl...

1d ago

Go to Apply

Account Manager

Illinois Employer • Des Plaines, IL • 1d ago

Management & Administrative

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/13564381 Acts as the primary liaison between Americaneagle.com and the client Docu...

1d ago

Go to Apply

Senior Manager, Software Engineering, Full Stack (Global Payment Network)

Capital One • Riverwoods, IL • 1d ago

Management & Administrative

Senior Manager, Software Engineering, Full Stack (Global Payment Network) Do you enjoy solving some of the most complex engineering challenges in financial technology? Are you passionate about building highly scalable, r...

1d ago

Go to Apply

Account Manager, Inside Sales Quill (B2B)

Staples • Lincolnshire, IL • 2d ago

Management & Administrative

Quill is a valuable part of the Staples family of brands. Since 1956, Quill has held its position as a leader in office supplies. Acquired by Staples in 1998, Quill delivers the essential services, solutions, and award-w...

2d ago

Go to Apply

Part Sales Manager - Part Time

AutoZone, Inc. • Antioch, IL • 2d ago

Management & Administrative

Job Description AutoZone's Store Management team drives store performance, fosters a productive team, and ensures exceptional customer service. Managers and MITs play a key leadership role, expected to Live The Pledge an...

2d ago

Go to Apply

Operations Manager

CVS Health • Glendale Heights, IL • 2d ago

Management & Administrative

We're building a world of health around every individual - shaping a more connected, convenient and compassionate health experience. At CVS Health®, you'll be surrounded by passionate colleagues who care deeply, innovate...

2d ago

Go to Apply

Operations Manager, AMXL-MDW8

Amazon • Waukegan, IL • 2d ago

Management & Administrative

Description ABOUT AMAZON Our Worldwide Operations network delivers millions of packages and smiles to Amazon customers every day. We are looking for motivated, customer-focused individuals who want to join our team as an...

2d ago

Go to Apply

Marketing Manager (Digital and Creative Design)

WESCO • Glenview, IL • 2d ago

Management & Administrative

As the Marketing Manager (Digital Experience & Technical Design), you will own the strategy, planning, and execution of digital experiences across Wesco's web platforms. You will lead a team of technical and digital...

2d ago

Go to Apply

Receiving Clerk

Cabela's • Hoffman Estates, IL • 2d ago

Management & Administrative

POSITION SUMMARY: The Receiving Clerk performs work in the Receiving area of the store to include merchandise stocking, inventory control, pricing and, merchandise returns. ESSENTIAL FUNCTIONS: Supports a strong commitme...

2d ago

Go to Apply

Manager, Software Engineering - B2B

Crate & Barrel • Northbrook, IL • 2d ago

Management & Administrative

The Manager, Software Engineering - B2B is a strategic and technical leadership role responsible for overseeing B2B functions at Crate and Barrel. This role includes ownership of B2B specific systems and end-to-end desig...

2d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)