Quality Manager

Manage, control, maintain, complete, and/or retrieve Scout documentation including, but not limited to, Quality, Operations, SOC2 Compliance documents, IT policies, vendor-related documents, and finance-related documents. 

Develop standardized templates and an organization-wide style guide to improve typography and content consistency. 

Create and ensure compliance with templates, style guides and training materials, and collaborating with technical writers. 

Create/revise, oversee the review of and maintain procedures, SOPs, Work Instructions, and obsolete documents. 

Establish release documentation schedule providing product-approved external release notes and related knowledge base content. 

Implement a cross-departmental Change Control Board (CCB), thus enabling a scheduled review cycle for documentation validity. 

Manage Change Request Process (CRP) to capture internal and external feedback and requests. 

Establish pre-publication content review and approval by Product Managers and client-facing support teams. 

Oversee the Change Management policy and activities, scheduling quarterly CM meetings or emergency change advisory board meetings, ensuring all documentation is gathered according to the plan, and changes are closed once the checklist is completed. 

Manage all staff training activities: ensure new hires receive regulatory and role-specific training during onboarding; ensure training is maintained and kept up-to-date. 

Manage customer complaint process by documenting all complaints, incidents and escalations, communicating with appropriate personnel/groups, and resolving in a timely manner. 

Perform internal audits. 

Oversee vendor for annual internal company audit, manage audit report, and collaborate on audit remediation with Sr. Quality Manager. 

Assist Sr. Quality Manager with client audits 

Complete all required initial and ongoing training within a reasonable or provided timeframe.  

Collaborate with the RFI Manager and Academy group on the Knowledge Base to support and improve the efficient completion of RFIs and Client Questionnaires. 

High School Diploma (required) 

Bachelor’s Degree (required) 

Minimum 3 years' experience in a management role

Experience working in a Regulated Industry (Medical Device, Pharma, Clinical Trials) environment preferred. 

Experience with Electronic Document Management Systems (e.g. Jira, Agile Cloud, Master Control, M-Files) preferred. 

Experience in planning for and participating in internal and external audits. 
 

Excellent communication and organizational skills 

Ability to use common software productivity tools, such as Word, Excel and PowerPoint