Essential Functions:
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Maintains all Engineering and Product Development records to ensure integrity and accessibility including but not limited to photocopying and scanning documents.
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Processes and controls storage of Quality Records.
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Interacts directly with users of controlled documentation to ensure internal conformance to company quality control requirements.
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Processes review and approval workflows in electronic document management system.
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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.
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Tracks and facilitates timely documentation review and implementation.
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Distributes documents in accordance to control procedures.
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Ensures accurate and timely input of database entries; implements a self-auditing system to verify work.
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Analyzes change requests for completeness.
- Provides support to internal customers with documentation needs.
- Updates electronic document profiles to reflect appropriate changes.
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Provides clerical and administrative support related to documentation processes and systems.
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Creates and maintains document templates by coding fields and uploading into the electronic document management system.
- Routes and releases documentation.
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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.
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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.
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Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications
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High school diploma or equivalent.
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Minimum two (2) years of experience in dental or medical device industry.
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Minimum one (1) year of customer service experience.
- Proficient skills in the MS Office Suite (Word, PowerPoint, and Outlook); advanced proficiency in Excel.
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Demonstrated knowledge of document control fundamentals, quality systems, and Good Manufacturing Practice (GMP) requirements.
- Demonstrated understanding of current medical device industry and applicable regulations.
Pay range: $23.00 to $25.00/hr
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
