{Job Junction} Urgent requirement for the position of Quality Engineer @ San Diego/CA

Please send the resume to vijay@rgtalent.com 

Hi,

Currently, I am recruiting candidates for one of my requirement as mentioned below. If you have a matching profile, please send me the updated resume along with contact details at the earliest.

 

Job Title	Quality Engineer
Project Location	San Diego CA
Duration	12 months /Contract

 
Skills Required and Job Description:

MOI: Telephonic + Skype Description This position will be responsible for working with the Associate Director of Quality to maintain an ISO13485 & 21CFR Part820 compliant Quality System for Astute Medical Inc a developer of in vitro diagnostics.    Reports to the Associate Director of Quality.  Emphasis will be placed on: Manage MasterControl system and configuration for documentation and training modules maintain DHFs in compliance to established procedures; execute trend analysis on Quality Systems for input into established Management Review procedure; assist in investigations and CAPA (leading root cause analysis & writing documentation); write software validation documentation; Responsible for ensuring internal/ external Quality System Requirements are adhered to throughout product and process lifecycles. Reporting on all of the above listed functionality Responsibilities 1.     Author documents for the Quality System including procedures, forms, and templates.  Assist with review, editing, and implementation of Quality System documents.  2.     Manage Master Control System documentation and training modules.  1.     Create Master Control user documents.  2.     Review documents for completeness, consistency, content, and format prior to uploading and routing in MasterControl.  3.     Responsible for the organization of MasterControl including the creation of vaults, routes, training, and custom reports.   Improve user interface with the MasterControl System and conduct training on the system as required.  4.     Develop and maintain an efficient method for the flow of documents through the MasterControl system in accordance with relevant document change control procedures. 3.     Responsible for organization and maintenance of Quality System Records and paper record retention of Quality System records.  4.     File, maintain and audit Design History documentation. 5.     Develops and executes (as required) training on GxP and annual Quality System training.  6.     Conducts internal and supplier audits as lead.  Writes audit plans, audit reports, and associated non-conformances and CAPAs.  Performs and leads root cause analysis with input from subject matter expert. 7.     Lead root cause investigations and documentation for non-conformities.  Reviews non-conformities for compliance and presence of objective evidence. 8.     QA lead for calibration and preventive maintenance programs.  9.     Creating and writing the following technical documents associated with the validation and implementation of a CRM (Customer Relationship Management system), an Inventory Management system, and an upgraded Document Management system: Requirements Specification, Risk Analysis, Verification / Validation Plan, Verification / Validation Protocol, Validation Report, & Traceability Matrix. 10.                        Identifies, initiates and leads process and compliance improvement.   Implements improvements and methods for measuring effectiveness of changes. 11.                        Identifies, tracks and reports key Quality Metrics for input into Management Review. 12.                        In-Depth knowledgeable of federal and other regulations, e.g. QSRs (Part 820 & Part 11), IVDD, ISO 13485. 13.                        Performs other duties & projects as assigned. Preferred educational background BS/BA degree in science or technical discipline or higher. Preferred experience: Typically 7+ years related experience. Strong emphasis placed on working with technical disciplines and understanding of product and process technologies Experience with federal, 3rd party agencies or regulatory agencies, e.g. 812 QSR's, ISO, ISO 13485, CMDR) and statistical sampling plans. Ability to work on multidisciplinary teams. Identifies and addresses all complexities of compliance issues Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks Demonstrates problem-solving and troubleshooting skills Strong verbal and written communication skills Demonstrates time management, decision making, presentation, and organization skills required. Proficient with Microsoft Office and Visio.

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Regards

Rugender Nagar

Technical Recruiter        

RG Talent Inc.

Phone :  510 443 0757 ext 106 Fax No. : 510-952-4633

Email : rugender@rgtalent.com

URL : www.rgtalent.com YIM/GTalk --> rugender.rgtalent

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