Quality Specialist III
Company: Planet Pharma
Location: San Jose
Posted on: August 8, 2022
Job Description:
Duties
- 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, specifically GCP and CDx support. 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.Skills
- 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 GCP requirements required.Education
- *Bachelors' degree in Biological Sciences, Engineering or
related field, or equivalent combination of education and work
experience. Requirements: Skills: * 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 GCP
requirements required. Education: * Bachelors degree in Biological
Sciences, Engineering or related field, or equivalent combination
of education and work experience.The Planet Group of Companies is
an equal opportunity employer. We celebrate diversity and are
committed to creating an inclusive environment for all
employees.
Keywords: Planet Pharma, San Jose , Quality Specialist III, Other , San Jose, California
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