Staff Quality Systems Specialist – Change Control

Wilson•Cary, IL

1d•Hybrid

About The Position

We are seeking a highly motivated Staff Quality Management Systems Specialist to support Quality Management System integration and harmonization activities within a regulated medical device environment. The successful candidate will lead and own the Change Control process, ensuring that proposed changes are properly documented, assessed for impact, approved, implemented, and verified in accordance with applicable quality and regulatory requirements. This position requires a strong understanding of how Change Control interacts with other QMS processes, including Document Control, Training, and Records Management. The specialist will work closely with cross-functional and international stakeholders, provide guidance to change owners, identify process gaps, and support the implementation of compliant and scalable quality system solutions. The role requires regular collaboration with teams in Germany and flexibility to accommodate Central European working hours.

Requirements

Bachelor’s degree in Engineering, Science, Quality, or a related discipline.
Minimum of five years of experience working within a regulated industry.
Demonstrated experience managing or supporting Change Control processes.
Experience supporting Quality Management System integration, harmonization, or process-standardization initiatives.
Strong knowledge of Quality Management Systems and applicable regulatory requirements, including FDA requirements, ISO 13485, and the European Union Medical Device Regulation.
Strong understanding of the relationship between Change Control, Document Control, Training, and Records Management processes.
Excellent technical-writing, documentation, and record-review skills.
Strong organizational, analytical, problem-solving, and project-coordination abilities.
Demonstrated ability to assess process gaps and develop compliant, practical, and scalable solutions.
Ability to mentor stakeholders, influence cross-functional teams, and promote consistent process execution.
Ability to manage multiple priorities and deadlines in a fast-paced environment.
Strong attention to detail and commitment to quality, accuracy, and compliance.
Proactive, collaborative, and solution-oriented approach.
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and SharePoint.
Fluency in written and verbal English.
Ability to work flexible hours to accommodate collaboration with teams operating in CET/CEST time zones.

Nice To Haves

Experience working within the medical device industry.
Experience applying EU MDR requirements in a medical device environment.
Experience supporting QMS integration following a company acquisition.
Experience integrating products, systems, processes, or acquired businesses.
Experience supporting global QMS integration or harmonization initiatives.
Experience collaborating with international or geographically dispersed teams.
Experience developing training materials or delivering coaching on quality system processes.
German-language proficiency, both written and verbal.

Responsibilities

Own and manage the Change Control process to ensure consistency, compliance, and effective execution.
Review and approve change records for completeness, accuracy, and appropriate impact assessment.
Ensure proposed changes are properly evaluated for their potential impact on products, processes, documentation, training, regulatory requirements, and quality records.
Monitor approved changes through implementation and closure.
Verify the completion of downstream activities, including document updates, employee training, system updates, and record-retention requirements.
Ensure change records contain sufficient objective evidence to demonstrate compliant implementation.
Support the integration and harmonization of Quality Management System processes across the organization.
Assess existing processes, identify gaps, and recommend compliant and scalable solutions.
Drive process standardization and continuous improvement initiatives related to Change Control and connected QMS processes.
Support the integration of products, systems, processes, or acquired business operations into the established Quality Management System.
Ensure integration activities align with business objectives, project timelines, and applicable regulatory requirements.
Identify quality and compliance risks and communicate recommended mitigation strategies to project stakeholders.
Mentor and guide change owners and cross-functional stakeholders on Change Control requirements and expectations.
Provide coaching on impact assessments, documentation standards, implementation planning, and change closure requirements.
Promote consistent and high-quality execution of change activities across the organization.
Serve as a subject-matter resource for Change Control and related quality system processes.
Influence stakeholders and drive accountability without direct reporting authority.
Develop, review, and revise quality system documentation, including procedures, work instructions, forms, templates, and change records.
Ensure documentation is clear, accurate, consistent, and compliant with internal requirements and applicable regulations.
Apply strong technical-writing practices to translate complex quality and regulatory requirements into practical process documentation.
Support document-control, training, and records-management activities associated with approved changes.
Partner with Quality, Regulatory Affairs, Research and Development, Operations, and other cross-functional teams to coordinate change and integration activities.
Act as a Quality representative during project meetings, process discussions, and QMS integration initiatives.
Collaborate with international teams, particularly stakeholders based in Germany.
Communicate project progress, quality risks, process gaps, and recommendations to key stakeholders.
Coordinate multiple priorities and deliverables in a fast-paced, integration-focused environment.