Quality Specialist

Location: Santa Clara, CA, United States
Date Posted: 09-13-2017
Position Role/Tile: Quality Specialist 
Location: Santa Clara, CA.
Req# : 7443386




Job Description:
The Quality Specialist,Sequencing will be a strong partner to the Global Quality and Regulatory function, as well as across the various Sequencing Solutions functions.
* Responsible for supporting development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and Clien'ts corporate requirements.
*Actively participate in quality integration efforts for the Santa Clara site by supporting the planning, implementation and monitoring of integration milestones.
* Responsible for supporting project-related and QMS documentation using Electronic Document Management System (EDMS). Support coordination of document and record retention program for the site in alignment with the Client's corporate requirements.
* Support management and maintenance of training assignments for the site. Track, monitor and report site training compliance data. Partner with department managers and trainers to develop/update training matrices.
* Write and revise Quality Systems procedures, perform gap assessments and assist in driving compliance.Understanding of laboratory procedures and GLP requirements is a plus.
* Experience in Change management, Supplier qualification, Inspection and CAPA management is an added advantage. Exposure to internal, external, laboratory, supplier auditing programs as appropriate.
* A proven ability to work creatively and analytically in a problem-solving and process-oriented environment. Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
* A proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.

Qualifications
* Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.
* 2-4 years related experience in relevant medical diagnostic/device industry, including 1-2 years of direct Quality operations.
Experience focused on quality systems, regulatory affairs/compliance or project management.
* ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus.
* Familiarity with relevant international ISO Standards (13485, 62304, 14971), and regulations (European medical/in-vitro devices directives, 21 CFR - part 820).
* Understanding of GMP and GLP requirements.

Competencies
* Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development of new products for our patients.
* Be flexible with changing priorities/tasks and a desire for continuous improvement.
* Drive to engage positively with Q&R/Business teams and make impact-full contributions in a multi-cultural/national environment.
* Strong interpersonal/communication/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations.

PROBLEM SOLVER
GMP
ASQ CERTIFIED
QUALITY SYSTEMS MANAGEMENT







Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (510)-713-9900, 510-573-5500 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com
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