Quality Specialist V
Company: Planet Pharma
Location: Santa Clara
Posted on: August 1, 2022
The Senior Specialist, Quality Systems will be a strong partner
to the Client Diagnostics Global Quality and Regulatory function,
as well as across the Client Information Solutions (RIS) Business
- Responsible for supporting development and implementation of
the Quality Management System (QMS) and supporting
infrastructure/tools in compliance with EU MDR, US FDA Quality
System Regulation (QSR) regulations, ISO 13485, and Client
corporate requirements within Q&R and cross functionally.
- Supports administration of the Management Review process via
establishment and reporting of Quality Management System
requirements and metrics.
- Provides project management leadership to various
Quality-driven initiatives and represents Quality as-needed for
representation in Company-wide improvement initiatives.
- Actively participate in quality audits and regulatory
inspection preparation efforts by supporting planning, gap
analysis, and mitigation implementation activities required to
comply with new regulations and standards.
- Responsible for supporting generation of QMS documentation
using the Electronic Document Management System (EDMS). Support
coordination of document and record retention program for the site
in alignment with the Client corporate requirements. Specifically,
prepare and route for approval project-related documentation. This
will involve managing many incoming documents and adhering to tight
schedules. May involve (pre-approved) off hours or weekend support
as milestone deadlines approach.
- Support in identifying gaps in the modular Quality Management
Systems procedures, performing gap assessments and assisting in
driving compliance. Understanding of quality system procedures in
the area of Digital Controls and cGMP requirements is a plus.
- Experience in Change Management, Inspection and CAPA Management
is an added advantage. Exposure to internal, external, 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 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 Life Sciences, Engineering or related
field, or equivalent combination of education and work
- 8+ years related experience in the relevant medical
diagnostic/device industry, including 3+ years of direct quality
systems experience, regulatory affairs/compliance, project
management, controlled documentation, quality data analytics, or
- Digital Quality Management System experience in design and
development of Software as a Medical Device (SaMD) is
- ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six
Sigma Green Belt a plus.
- Familiarity with relevant international ISO Standards (e.g.,
13485:2016, 14971:2019, 27001, etc.), and regulations (EU MDR/IVDR,
21 CFR - part 820). Direct experience working in a US FDA regulated
- Understanding of GXP requirements preferred.Competencies
- Enthusiasm for the role that Quality and Regulatory (Q&R)
can play in enabling the development and manufacture of new
products for our patients.
- Be flexible with changing priorities/tasks and a desire for
- Drive to engage positively with Q&R/Business teams and make
impactful contributions in a multi-cultural/national
- Strong interpersonal/communication/integrating/problem-solving
skills and demonstrated ability to collaborate effectively across a
variety of workgroups in demanding/changing situations.
Keywords: Planet Pharma, Santa Clara , Quality Specialist V, Other , Santa Clara, California
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