$52,000-- Seeking experienced Professional Document Control Specialist!!

Location: Irvine
Posted on: July 18, 2021

Job Description:

PURPOSE OF JOB: Completes a wide variety of assignments under general supervision within the scope of medical device document control. These assignments include support of electronic and manual record management activities such as word processing, archival, retrieval, records modification, and verification. Works under normal supervision on routine work and received detailed instructions and oversight on new assignments. Performs all responsibilities in compliance with company policies and procedures.

ESSENTIAL FUNCTIONS:

1. Leads and maintains the change control process. This includes the preparation of the change requests, insuring the appropriate functional reviews and sign-off, and maintaining the records of the changes. Posts changes to computerized or manual files, releases documents, and notifies affected departments.

2. Maintains an established data distribution system and expedites review, signature approval and release of documentation in a timely manner.

3. Analyzes and develops recommendations to improve documentation current processes.

4. Responsible for maintaining the Expandable ERP documentation database and the change control database

5. Administration of the training effectiveness program, including data entry/maintenance, tracking, and reporting.

6. Confers with change originators to prepare documents and change requests. Works with document originators to resolve discrepancies in order to make required changes to the documentation.

7. Responsible for maintaining the existing record retention process.

8. Participates in the creation of new processes and revision of existing processes to improve the Quality Management System.

9. Organizes and maintains active, obsolete, and computerized files which support the documentation system, including device master records, design history records, and labeling.

10. Support various special projects support for regulatory compliance and to meet company-wide quality objectives.

OTHER RESPONSIBILITIES:

1. Interface with other Company departments as required.

2. Assist in compilation and preparation of information for various summary reports, including complaint and NCR summaries, for quality system management review or as otherwise required.

3. Assist in third party inspections and audits, and internal audits.

4. Provide controlled documents to other departments as requested.

5. Maintain professional and technical knowledge by continuing education.

6. Perform other responsibilities as assigned.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

1. Possesses willingness to learn complex subjects with a minimum of instruction and/or supervision.

2. Possesses working knowledge of computers (word processing, spreadsheets, databases, etc.).

3. Minimum of high school diploma, with a bachelor's degree preferred, and one to two years' experience, preferably in the medical device industry in Engineering-related or Document Control functions required.

4. Ability to read and develop technical drawings or prints.

5. Must be a self-starter and hands-on, with excellent organizational, oral, and written communication skills.

We are an equal employment opportunity employer and will consider all qualified candidates without regard to disability or protected veteran status.

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