Primary QMS Work Stream Lead

Primary QMS Work Stream Lead#26-01010 Chicago, IL

Fully Remote Job Description At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Primary QMS Work Stream Lead.

Position Type:

Contract Remote

Required:

Bachelor's degree in a technical or scientific discipline, or equivalent experience in quality systems within a regulated industry. 8+ years of experience in Quality Management Systems, preferably in the medical device industry. Strong expertise in QMS elements such as Management Control, Document Control, and Training, including remediation and process improvement initiatives. Demonstrated knowledge of medical device regulatory requirements, including

FDA 21 CFR

820 and

ISO 13485.

Proven experience leading or supporting cross-functional quality system remediation programs in response to audits, inspections, or regulatory findings. Strong analytical, organizational, and technical writing skills, with the ability to develop regulatory-ready documentation and executive-level reports. Excellent communication and stakeholder management skills, with the ability to collaborate across multiple sites and influence process improvements.

Responsibilities:

Serve as the Subject Matter Expert (SME) for Quality System Elements (QSE) including Management Control, Document Control, and Training within the QMS remediation workstream. Lead and support QMS review and remediation initiatives, addressing compliance gaps and strengthening system-level quality processes. Provide expert guidance on root cause analysis, risk assessment, effectiveness checks, and sustainable corrective actions to resolve systemic issues. Implement and monitor interim controls and risk mitigation measures during remediation CAPA investigations to maintain compliance and operational stability. Lead or support the redesign and implementation of QSE processes, ensuring alignment with regulatory standards and organizational quality objectives. Develop and maintain metrics, dashboards, and reporting tools to track remediation progress, identify trends, and drive continuous improvement. Deliver training, mentorship, and cross-functional guidance to strengthen adherence to QMS processes and promote long-term compliance. Get in

Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Rishaw at 862-895-5483 to learn more. #LI-VK1 #HbM6349