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Job Field: Legal Jobs
Location: Santa Clara, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Position Summary
This position is meant to manage the internal and
external documentation  by establishing a dynamic
document control system based on QAD database.
The function will support compliance activities
related to the MRP system and document and data
reflected by control documentation and records.
This position is instrumental in supporting
internal and external audits that demonstrate
adherence to the regulatory and statutory
requirements.
Principal Accountabilities
Manage the Device Master Record DMR
documentation and establish high level of accuracy
for the product DMR and Bill of Materials BOM.
Extensive knowledge of QAD ERP system is
necessary.
Manage and control Quality System documentation,
including but not limited to Standard Operating
Procedures, Work Instructions, Equipment Change
Orders, Validation Reports, Device History Files,
Batch Records, and Design History Files.
Develop, write and implement procedures related to
the document control process.
Review Standard Operating Procedures and
Engineering Change Orders to ensure that they meet
the requirements outlined in the document control
procedures.
Manage process for implementing new and revised
documents in the Quality System.
Establish an efficient electronic distribution
system in order to allow the personnel to
concomitantly review the documents subject to
changes.
Establish controlled electronic locations
folders for RELEASED, ARCHIVED and CCB
documentation.
Manage the controlled locations for the documents
control documentation binders, or suppliers by
establishing a controlled distribution list for
each released document.
Distribute approved documents as required in a
timely manner to ensure the most recent revision
is available to associates.
Maintain the required documentation for each SOP
master file, manage master log of all documents,
and issue weekly updates on the status of all
documentation changes.
Archive the lot history batch records.
Maintain the Document Control databases.
Review Document History Record DHR and other
records and perform other duties as required.
Interact and coordinate document requirements with
other departments.
Identify and implement opportunities for
continuous improvement and provide training to
plant associates as necessary.
Support internal and external audits.
Additional Duties
Perform training record audits.
Develop, with support from the department managers
the training requirements for each BARRx Medical
personnel.
Perform the Lot History Record review and
periodical audits.
Support marketing department in the review process
for marketing and training literature.
Interact with management team to define and
develop the document control charter as needed.
Maintain fiscal responsibility and budget
compliance.
Perform quality system training for the document
control related activities.
Requirements
Education Requirements
BS preferred
Experience Requirements
7+ years of industry experience.
Computer experience required.

KEY REQUIREMENTS:

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None Bachelors degree