Quality Management System (QMS) Documentation Specialist

 

JOB DESCRIPTION

Position Title: Quality Management System (QMS) Documentation Specialist

Job Location: Fremont, CA, USA

Department: Document Control

FLSA Status: Non-exempt

Reports to: Technical Operations Manager

Last Modified: 07/24/08

Incumbents:

 

 

Position Summary:

The function of this position is to support QMS Implementation, internally and externally.  The main responsibilities for this position are the management of the documentation and maintaining the compliance of the company’s ISO 9001:2000 certification program.  Other responsibilities include processing RMA and coordinating document control procedures and policies.  This position requires the candidate to effectively manage their time and to multi-task.  The individual in this position is expected to be self-directed and carry out assignments independently with minimum supervision.

 

 

Job Duties and Responsibility:

·         Review, revise and maintain QMS controlled documents including Quality Manual, Process Diagrams, Quality Procedures, Work Instructions and forms

·         Review, revise and maintain databases for Audits, Corrective Action, Preventive Action and Continual Improvement Activities and report to the ISO Management Representative

·         Conduct internal ISO9001:2000 audits

·         Maintain Corrective Action and Supplier Corrective Action records

·         Conduct and lead Root Cause Analysis activities

·         Compile and maintain control records and related files to drawings, and engineering documents to manufacturing and other operating departments (such as spec documents, test procedures, project folders, etc.)

·         Examine documents such as drawings, change orders, and specifications to verify completeness and accuracy of data

·         Confer with document originators or engineers to resolve discrepancies and compiles required changes to documents

·         Process Engineering Change Orders

·         Issue, Process & Maintain RMA (Return Material Account) records – includes assigning RMA # to customer, coordinating repair/diagnostics with tech department, quote to customer, authorize repair to tech department, coordinating the return of the repaired unit

·         Maintain numerical, alphabetical, chronological and/or subject filing system

·         Other duties as assigned

 

 

Required Job Skills:

·         Proficient knowledge of ISO9001:2000

·         Good communication skills in verbal and written English

·         Proficiency in using Microsoft Word, Excel, Project and Power point

·         Knowledge of FileMaker Pro is desirable

·         Experience with document management systems is desirable

·         Ability to focus for extended periods on detailed technical information, identify and resolve discrepancies

·         Strong organizational and time-management skills

·         Strong interpersonal skills

·         Able to work in stressful environment and prioritize work to ensure timely completion of all work

·         Ability to multitask and focus in face of repeated interruptions and demands

·         Ability to prioritize among numerous competing demands to ensure work is timely completed

·         Ability to interface effectively with teams with competing demands and facilitate appropriate resolutions to meet operating needs

·         Good critical thinking skills and ability quickly and accurately to analyze numerous types of data and determine appropriate course of action, appropriate negotiation strategy, and appropriate goals

·         Ability to manage costs of department operations within budget

·         Ability to sit for long single periods analyzing and reviewing data and documents, writing reports, preparing proposals and presentations and attending meetings

·         Strong presentation/public speaking skills for purposes of making presentations to prospective vendors, and in internal meetings

·         Flexibility to work long hours and/or weekends from time to time based on operational needs

·         Ability to organize and control (and keep organized and controlled) vast amounts of data and paperwork in logical manner, enabling ready and easy access for self and coworkers

 

 

Educational Qualifications and Professional Experience:

·         3-5 years of Document Control / ECO Coordinator in an engineering environment

·         3+ years in QMS implementation

·         3+ years as ISO9001:2000 internal auditor

·         2 year minimum degree or equivalent experience is preferable

 

 

Work Environment & Physical Demands

·         The work environment characteristics described here are representative of those an employee encounters while performing the essential job functions of this position.  Reasonable accommodations will be made to enable individuals with disabilities to perform essential functions

·         Work is performed in typical United States office environment

·         Requires occasional domestic travel by car and/or air

·         Requires weekend work on occasion and on short notice

·         The employee must have ability to deal with moderate to high stress levels from the pressure of deadlines and daily dealings with demanding work

·         The physical demands described here are representative of those that must be met by an employee to successfully the carry out the essential job functions of this position.  Reasonable accommodations will be made to enable individuals with disabilities to perform essential functions

·         While performing the duties of this position, the employee is required to frequently sit for extended periods and occasionally must stand, walk, use hands and fingers and reach with hands and arms.  The employee must occasionally lift and/or move up to 25 pounds.  In addition, employee must be able to perform considerable keyboarding duties on company-provided computer.

·         Specific vision abilities include the ability to read and analyze data in hard copy and on a computer screen, measure or identify using eyesight and adjust vision focus.