- Location: IL, United States
- Type: Contract
- Job ID: 10423
- Work Setting: On-Site
- Posted: June 24, 2026
- Closing Date: June 18, 2027
- Tax Status: W2
Staff Quality Systems Specialist
12-month Contract
Hybrid in Cary, IL
Must be able to work on a W2
Pay Rate: Starting at $50/hr
Requirements
12-month Contract
Hybrid in Cary, IL
Must be able to work on a W2
Pay Rate: Starting at $50/hr
Requirements
- Support Quality Management System (QMS) integration activities by leading and owning the Change Control process within a regulated medical device environment.
- 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 such as documentation updates, training completion, and 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.
- Work flexibly to accommodate collaboration with teams operating in German time zones (CET/CEST).
- Bachelor’s degree in Engineering, Science, or a related field.
- Minimum of 5 years of experience in a regulated environment, preferably within the medical device industry.
- Proven experience with Change Control processes and quality system integration or harmonization.
- Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements, including FDA, ISO 13485, and 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, both written and verbal.
- Ability to work flexible hours to accommodate German time zones.
- Experience supporting the integration of products, systems, or acquired businesses.
- Experience supporting QMS integration in a global environment.
- German language proficiency, written and verbal.