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Form of workJob Description
Essential Functions:
- Maintains all Engineering and Product Development records to ensure integrity and accessibility including but not limited to photocopying and scanning documents.
- Processes and controls storage of Quality Records.
- Interacts directly with users of controlled documentation to ensure internal conformance to company quality control requirements.
- Processes review and approval workflows in electronic document management system.
- Reviews document format to ensure compliance to Good Documentation Practices (GDPs).
- Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding marketed products, as requested.
- Tracks and facilitates timely documentation review and implementation.
- Distributes documents in accordance to control procedures.
- Ensures accurate and timely input of database entries; implements a self-auditing system to verify work.
- Analyzes change requests for completeness.
- Provides support to internal customers with documentation needs.
- Updates electronic document profiles to reflect appropriate changes.
- Provides clerical and administrative support related to documentation processes and systems.
- Creates and maintains document templates by coding fields and uploading into the electronic document management system.
- Routes and releases documentation.
- Follows up on training requirements to ensure compliance to the department’s standard operating procedures.
- Assists with monitoring the Document Control email inbox to ensure all requests are assigned and responded to in a timely manner. Communicates among the Document Control team to ensure request are fully completed.
- Maintains the document archival room; ensures files are accurate and easily retrievable.
- Assists with training program by filing training records and logging training.
- Works with a variety of internal teams to ensure receipt of training materials.
- Performs other related duties and projects as business needs require at direction of management.
Education and Experience:
- High school diploma or equivalent.
- Minimum two (2) years of experience in dental or medical device industry.
- Minimum one (1) year of customer service experience.
Pay: $22.51-$30.01/hr
