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Quality Specialist II

Santa Clara, CA
Position Role/Tile: Quality Specialist II
Location: Santa Clara, CA.

* 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 Client 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.

* Experience in Change management, Supplier qualification, Inspection and CAPA management is an added advantage.
Exposure to internal, external, laboratory, supplier auditing programs as appropriate.

* Good to have experience in 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 corporate requirements.

* 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.

* Familiarity with relevant international ISO Standards (13485, 62304, 14971), and regulations (European medical/in-vitro devices directives, 21 CFR - part 820).

* ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus.

* Understanding of GMP and GLP requirements.
Keywords Education * Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.

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: (833)247-8800 Fax: (510)-740-3677

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