NEW JOB OPENING
QUALITY SYSTEMS SPECIALIST
IN CARY, IL, USA!

 

Date Posted: 06/24/2026
Hiring Organization: Rose International
Position Number: 503268
Industry: Medical Equipment & Supplies
Job Title: Quality Systems Specialist
Job Location: Cary, IL, USA, 60013
Work Model: Hybrid
Work Model Details: 3 days in office, 2 work from home
Shift: 8am-5pm with flexibility to accommodate German local working hours
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 13
Min Hourly Rate($): 50.00
Max Hourly Rate($): 58.00
Must Have Skills/Attributes: Documentation, Technical, Verbal Communication
Experience Desired: Quality Systems and Change Control experience in FDA-regulated medical devices (5-10 yrs); Quality Systems experience, including Change Control (5-10 yrs); QMS integration, harmonization, and acquisition-related quality initiatives (5-10 yrs); Managing controlled quality documents, including SOPs, work instructions, and records (5-10 yrs); Process standardization and continuous improvement in ISO 13485 and EU MDR environments (5-10 yrs)
Required Minimum Education: Bachelor’s Degree

**C2C is not available**

 

Job Description

Required Education:
• Bachelor’s degree in engineering, Science, or a related field

Required Experience/Skills:
• 5+ years of experience in a regulated environment (medical device preferred)
• Proven experience with Change Control processes and quality system integration or harmonization
• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements (e.g., 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 consistent process execution across cross-functional teams
• Ability to manage multiple priorities in a fast-paced, integration-focused environment
• Strong attention to detail and commitment to quality and compliance
• Collaborative mindset with a proactive, solution-oriented approach
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and SharePoint
• Fluency in English (written and verbal)
• Ability to work flexible hours to accommodate German time zones
• Experience working closely with teams in Germany and aligning with CET/CEST working hours

Preferred Experience/Skills:
• Experience supporting the integration of products, systems, or acquired businesses
• Experience supporting QMS integration in a global environment
• German language proficiency (written and verbal)

Quality Systems Specialist Overview: This position is ideal for a detail-oriented professional with strong technical writing skills and a deep understanding of how quality system processes interact (e.g., change control, document control, training, and records management).

Quality Systems Specialist Job Duties:
• Own and manage the Change Control process to ensure compliance, consistency, and effectiveness
• Review and approve change records for completeness, accuracy, and appropriate impact assessments
• Ensure changes are implemented appropriately, including verification of downstream activities (e.g., documentation updates, training completion, record retention)
• Drive process improvements and standardization to support integration efforts
• Evaluate process gaps and define compliant, scalable solutions
• Collaborate with cross-functional teams to align change activities with integration timelines and business needs
• Mentor and guide change owners and stakeholders on proper change control processes
• Provide coaching on impact assessment, documentation expectations, and process requirements
• Promote consistent and high-quality execution of change activities across the organization
• Develop and revise quality system documentation, including procedures, work instructions, and change records
• Ensure documentation is clear, accurate, and compliant with internal and regulatory requirements
• Partner with Quality, Regulatory, R&D, and Operations teams to ensure alignment on changes and integration efforts
• Act as a quality representative in project discussions and integration activities
• Communicate progress, risks, and recommendations to key stakeholders
• Support quality system integration and harmonization activities in a regulated environment
• Maintain compliance while driving effective change management across the organization

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

 

Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

 

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About Rose

  • Founded in 1993
  • Office Locations Across the U.S.
  • 150+ Clients: Corporations and Government Agencies
  • Employee Oriented Company
  • Challenging Assignments Across the U.S.
  • Continuous Professional Development

Your team at Rose International is always very helpful and responsive.

Barbara, Consultant

My on-boarding with Rose was outstanding. The packets of information, the process, and great attention to detail each person gave me allowed me to get started quickly.I appreciated each person's friendly and helpful attitude.

Diana, Consultant

It was great working for Rose International. Everyone was extremely helpful.

Rosann, Consultant

As a contractor, I have to say that Rose International was by far the best agency I have worked for.

Q'testdalir, Consultant

It is a great pleasure being a part of the Rose International Team.

Toni, Consultant

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