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Document Control Specialist
The Document Control Specialist maintains and improves the document control process in a regulated medical device manufacturing environment.
Responsibilities:
* Operates and maintains document control processes and data.
- Executes document controls and manages changes.
- Oversees the distribution of new controlled documents, procedures and instructions.
- Completes and executes Engineering Change Orders.
- Maintains Device Master Record
- Develops filing & document control procedures & implements electronic systems.
- Proactively improves, facilitates or communicates the status of all changes to the team and all levels within the organization.
* Department Training Representative
- Identifies Operations personnel training requirements.
- Coordinates procedure-based training as required.
- Maintains records of training compliance.
- Provides & gives guidance to other staff as to policies, procedures, manuals, etc., that make up the Document Control System.
- Works in close contact with QA, Manufacturing, Materials, Engineering in writing and preparing control documents.
* Assists as required in the Receiving Inspection process.
- Ensures incoming material meets inspection criteria.
- Identifies product requiring First Article Inspection.
- Routes and tracks product through the First Article Process
- Maintains records of FAI
* Assists in conducting Internal Audits.
* Other tasks and duties as defined by supervisor
Knowledge, Skills & Ability:
* Expertise in using Microsoftİ Office Suite of applications required
* Experience in using automated document control systems desired.
* Familiarity with current electronic document practices, e.g. scanning, file management, etc.
* Ability to lift & move 20 lb containers.
Qualifications:
* High school diploma required; BA or business equivalent preferred.
* Required 3 - 5 years experience in a document control position.
Email résumé: HumanResources@intouchhealth.com
Questions: Click here to submit a question.
Only candidates of interest will be contacted.
No agencies or phone calls. |
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