Senior Quality Systems Specialist

QMS, Change Control, Medical Device, and Integration Project

Location: Cary, IL

Schedule: Hybrid (3 days onsite / 2 days remote)

Duration: 18-Month Contract

Hours: Monday–Friday, 8:00 AM–5:00 PM (flexibility required to collaborate with international teams)

Pay range: $50-$55/hour

Job Description

We are seeking a highly motivated Staff Quality Systems Specialist (Contractor) to support QMS integration activities by leading and owning the Change Control process within a regulated medical device environment. In this role, you will ensure that all changes are appropriately documented, assessed for impact, and effectively implemented in alignment with quality and regulatory requirements. You will also mentor cross-functional stakeholders on proper change execution and support the integration of quality system processes across the organization.

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). This role requires close collaboration with teams in Germany and flexibility to align with CET/CEST working hours.

Responsibilities

• 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

Qualifications

• Bachelor’s degree in engineering, science, or a related field
• 5+ years of experience in a regulated environment (medical device preferred)
• Proven experience with Change Control processes and quality system integration or harmonization
• Experience supporting integration of products, systems, or acquired businesses is strongly preferred

Required

• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements (e.g.