Document Control Specialist

East Bay, CA | Temp To Perm

Post Date: 08/12/2015 Job ID: 3051 Industry: Medical Devices

Primary Responsibilities and Duties:

Open, track, and process Engineering Change Orders.

Maintain engineering drawings.

Create and maintain Device Master Record indices.

Issue and control revisions of controlled documents.

Maintain Quality System documents; Quality Manual, Quality Procedures, Quality Forms, Work Instructions.

Maintain master document files.

Maintain training files.

Provide administrative and word processing support as requested.

 

Experience, Education, Training, and Skills:

Education beyond High School desired

Five (5) plus years work experience

Three (3) plus years' experience in Document Control or Quality Assurance in

FDA regulated Medical Device industry

Ability to perform tasks with a high level of accuracy.

Good intemersonal communication skills

Computer and Software Skills:

Strong computer skills; proficient in Excel, Word, MS Access, Visio, Adobe Acrobat, file manipulation

Solidworks experience desirable

Language and Verbal Skills

• Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally. Individual must

have clear and confident oral presentation skills. Must be detail oriented and able to work independently. Strong work ethic and sense of personal responsibility required.

Math Skills

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical and Reading Skills

Ability to read, analyzes, interpret and assist in the creation and refinement of company procedures. Ability to define problems collects data, establish facts, draw valid conclusions and report on findings.

Physical Requirements

Wiile performing the duties of this job, the employee may be required to perform lifting tasks of up to 25 pounds for short durations. Duties of this job may involve sitting,

standing and/or walking for extended periods of time. Duties also involve daily keyboard

data entry. Specific vision abilities required by this job include close vision. Must be able to reach with arms and hands, use hands to finger, handle and feel.

Work Environment

Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.

Safety

Our company is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.


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