Company
DocumentationControl
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Documentation Control. Skills: documentation control, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Support documentation and training activities within the Global Management System (GMS) and legacy systems. Maintain document control, retention, and change control processes and associated tools”
What You'll Achieve.
Prepare KPIs, reports, dashboards, and presentations related to documentation control and compliance processes; Ensure activities are completed within defined timelines
What They're Looking For.
Must Have
Bachelor’s degree in Scientific, Medical, Technical, or related field, Minimum 5 years of overall work experience, Minimum 3 years of experience in Medical Devices or Pharmaceutical industry, Knowledge of applicable standards and regulations such as ISO 13485, ISO 9001, ISO 14001, GxP, and MDSAP, documentation, compliance, coordination, and communication skills
Nice to Have
Experience with electronic document management systems and integrated quality management tools preferred
What You'll Do.
Support documentation and training activities within the Global Management System (GMS) and legacy systems
Maintain document control
and change control processes and associated tools
Support electronic document management systems such as QDOK and Windchill including user management
Conduct periodic review of controlled documents and support document lifecycle management activities
Participate in continuous improvement initiatives related to workflows
and harmonization of legacy systems
Perform document change requests
formal document reviews
and controlled document updates
Support translation and implementation activities for controlled documents
Prepare Local Implementation Requests (LIR) and related documentation activities
Support regulatory training processes and associated systems/tools
and presentations related to documentation control and compliance processes
Maintain electronic collaboration and document storage platforms such as MS Teams and SharePoint
Ensure activities are completed within defined timelines and maintain training records/evidence
How You'll Work.
Communication Scope
communication skills
Full Job Description
**Key Responsibilities:** • Support documentation and training activities within the Global Management System (GMS) and legacy systems. • Maintain document control, retention, and change control processes and associated tools. • Support electronic document management systems such as QDOK and Windchill including user management, troubleshooting, and training. • Conduct periodic review of controlled documents and support document lifecycle management activities. • Participate in continuous improvement initiatives related to workflows, eDMS tools, and harmonization of legacy systems. • Perform document change requests, formal document reviews, and controlled document updates. • Support translation and implementation activities for controlled documents. • Prepare Local Implementation Requests (LIR) and related documentation activities. • Support regulatory training processes and associated systems/tools. • Prepare KPIs, reports, dashboards, and presentations related to documentation control and compliance processes. • Maintain electronic collaboration and document storage platforms such as MS Teams and SharePoint. • Ensure activities are completed within defined timelines and maintain training records/evidence. **Qualifications:** • Bachelor’s degree in Scientific, Medical, Technical, or related field. • Minimum 5 years of overall work experience. • Minimum 3 years of experience in Medical Devices or Pharmaceutical industry. • Knowledge of applicable standards and regulations such as ISO 13485, ISO 9001, ISO 14001, GxP, and MDSAP. • Experience with electronic document management systems and integrated quality management tools preferred. • Strong documentation, compliance, coordination, and communication skills.
Applying for this Documentation Control role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about this company?
Real rants from real employees. Read before you apply.