Quality Systems Specialist III
Posted on: November 18, 2021
Responsible for general support and maintenance of the Quality
System within the requirements of FDA's Quality System Regulation
(QSR) and ISO 13485 (ISO). Specifically, functions including record
review, product release and document control fall under this
Shift: Wed-Sat (8:00pm to 6:30am)
ESSENTIAL JOB RESPONSIBILITIES:
Review records and documents, for completeness and compliance with
QSR and ISO requirements.
Review batch record to support release of raw materials, work in
progress and final products. This includes reagents, components and
Collaborate with other function teams to resolve batch record
discrepancies or errors as it related to Good Documentation
Assist to improve standard operating procedure and improve quality
Support the Material Review Board, for the assessment and
disposition of non-conforming materials and closure of
Non-conformance and Deviation Report, as needed.
Support PDR closure, as needed.
May lead and participate in interdepartmental initiatives for
Provide guidance on general quality principles and specific
Perform and complete work with a limit degree of supervision.
May provide continuous improvement to the processes and
May provide on-job training and/or qualification exam to junior
Complete the assigned tasks, as needed.
TRAINING RESPONSIBILITIES: (REQUIRED)
Complete all assigned and required training satisfactorily and on
Education and Experience (in years):
High School degree (or equivalent experience) with 4-6 years of
related work experience OR
AA or Technical Degree with 2-4 years of related work
Knowledge and Skills:
Excellent verbal and written communication skills in group or
Ability to interface well with people of varied backgrounds, and to
guide groups toward effective dynamics.
Understanding of general mathematical principles and
Ability to perform routine statistical applications.
Experience in compiling data to support metrics analyzing current
Understanding the general laboratory failure investigation,
qualification/validation process, root cause analysis, and
Computer skills: Microsoft Office: word, excel, access, power
point, Microsoft project; Agile, SmartSolve, MES and XpertERP.
Experience in DNA diagnostics or other medical devices
Experience in Kaizen, Daily Management (DM) and GEMBA.
The statements in this description represent typical elements,
criteria and general work performed. - They are not intended to be
an exhaustive list of all responsibilities, duties, and skills for
When you join us, you'll also be joining Danaher's global
organization, where 69,000 people wake up every day determined to
help our customers win. As an associate, you'll try new things,
work hard, and advance your skills with guidance from dedicated
leaders, all with the support of powerful Danaher Business System
tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies require all US and
Puerto Rico employees to be vaccinated against COVID-19 as a
condition of employment, subject to reasonable accommodation as
required by law.
Danaher Corporation and all Danaher Companies are committed to
equal opportunity regardless of race, color, national origin,
religion, sex, age, marital status, disability, veteran status,
sexual orientation, gender identity, or other characteristics
protected by law. We value diversity and the existence of
similarities and differences, both visible and not, found in our
workforce, workplace and throughout the markets we serve. - Our
associates, customers and shareholders contribute unique and
different perspectives as a result of these diverse attributes.
The EEO posters are available here .
We will ensure that individuals with disabilities are provided
reasonable accommodation to participate in the job application or
interview process, to perform crucial job functions, and to receive
other benefits and privileges of employment. Please contact us at
email@example.com to request accommodation.
If you've ever wondered what's within you, there's no better time
to find out.
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