Job Description
Job Description
Support the implementation and ongoing maintenance of electronic document control systems including managing controlled documents, including quality system procedures, records, and product and marketing materials. Create, update, and implement related procedures to ensure Company compliance to Company policies and procedures.
Responsibilities:
- Support day-to-day maintenance of the Company’s electronic Document Control System (DCS) software, such as MasterControl and SmartSheet.
- Support ongoing DCS configuration, upgrades, and validations.
- Manage all phases of document change control, including document submission, review, approval, archiving, and maintenance of the quality system document list.
- Collaborate with other functional groups on the improvement of document control procedures.
- Manage the control of procedures, records, product and marketing materials in a consistent, organized fashion. Identify efficient workflows for cross-functional approvals, such as scheduling and leading routing calls.
- Update training materials to reflect new or updated procedures in the Company training systems.
- Identify and assign applicable trainings in training plans per employee roles.
- Participate in audit preparation, locating applicable quality system documents and records.
- Participate in continuous improvement projects such as corrective and preventive action.
- Identify guidance documents, international standards, or consensus standards related to documentcontrol and provide support in identifying needed procedural updates for compliance.
- Review documents for technical writing, format, grammar, and compliance with quality system procedural requirements.
Education Requirements & Previous Experience:
- Experience using Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).
- Bachelor’s degree preferred
- 2+ years of relevant experience within a regulated industry, preferably medical device
- Strong verbal and written communication skills, attention to detail, and organizational skills
Company DescriptionMedical Devices
Company Description
Medical Devices