Staff Specialist (Quality Management/Change Control)

Staff Quality Systems Specialist - (Medical Device Industry)

Location : (ONSITE) - Cary, IL (60013)

Duration : 18+ month contract

Type: W2 contract ( C2C OR THIRD PARTY arrangements will NOT be considered for this role)

Pay: Negotiable depending on direct-related experience up to $48 - $52 an hour

Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer requirements. Sponsorship is unavailable for this role.

Job Summary:

• 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).

MUST HAVE:

• Change Control & Quality Systems Management
• Cross‑Functional Collaboration & Stakeholder Management
• Process Improvement & Compliance Expertise

Job Duties:

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

• 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

Required:

• Bachelor’s degree in engineering, science, or a related field
• 5+ years of experience in quality systems, regulatory, or compliance roles within a regulated industry (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
• 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

Preferred:

• Experience supporting QMS integration in a global environment
• German language proficiency (written and verbal)

Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer requirements. Sponsorship is unavailable for this role.

Important information: To be immediately considered, please send an updated version of your resume to View email address on click.appcast.io.

*** (Kelly does not expense relocation/interview costs)**