Staff Specialist, Quality Management Systems

Hybrid in Cary, IL

Pay: $55.87/hr.

Duration: 12 months, Contract, W-2

Shift: M-F 8:00 AM - 5:00 PM with flexibility to accommodate German local working hours

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.

* 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 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

* Experience supporting QMS integration in a global environment

* German language proficiency preferred (written and verbal)

* 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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.