Senior Quality Systems Specialist
Posted on: June 12, 2021
Cepheid is seeking a Senior Quality Systems Specialist
responsible for evaluating and improving the Quality Management
System by employing best practices to ensure compliance to
applicable Medical Device and IVD regulations/standards and Danaher
Polices. The Senior Quality Systems Specialist will participate in
the Cepheid QMS internal audit program to verify compliance to
internal Cepheid Quality Policies and Standard Operating
Procedures, and external regulatory and customer requirements. The
Senior Quality Systems Specialist will support FDA, ISO, Danaher
corporate, and other external audits. The Senior Systems Specialist
will also participate in the CAPA program by working closely with
CAPA owners and provide guidance on CAPA documentation.
ESSENTIAL JOB RESPONSIBILITIES:
- Functions as Lead Auditor to schedule, plan, perform, and
document internal audits of Cepheid's QMS.
- Ensures that all internal audit findings are closed in a timely
manner with effective corrective action by assisting observation
owners on investigations, action plans, and/or verification
- Participate in MDSAP preparation, assessment, and audit
- Participates in external audits (e.g. FDA, ISO, Danaher
- Working with CAPA owners to plan and document investigations,
action implementation and effectiveness verification on time and
according to procedure.
- Provide continuous and rigorous assessment of the Quality
Management System including CAPA, Internal Audit, and other
processes as necessary to identify and implement improvements.
- Be a subject matter expert on Internal Audit and CAPA
- Build working relationships with cross functional teams
including Development, Supply Chain, Program Management, Commercial
Operations, Regulatory Affairs, etc. to ensure process solutions
are compliant, efficient and adaptable to business units, sites and
functions throughout the world.
- Collaborates across the organization at all levels, across
functional groups and geographic locations, including executive
- Implement tactical plans to meet Company and Corporate
objectives, and supporting the development and implementation of
policies to ensure compliance with applicable US Federal and local
- Maintains up-to-date knowledge and ensures compliance with
local, state, and federal regulations and standards including
compliance with Food & Drug Administration (FDA) and European Union
In Vitro Diagnostic Regulation (IVDR) as well as other applicable
global regulatory requirements.
Education and Experience (in years):
- Bachelor's degree in field with 5 years of related experience
or Master's degree in field with 3 years of related experience or
Doctoral degree in field with 0-2 years of related work
Knowledge and skills:
- Excellent verbal and written communication skills.
- Lead Auditor Certification or CQA(B)
- Possesses significant knowledge of domestic and international
quality systems and other standards such as FDA QSR, IVDR, CMDCAS,
SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and
- Ability to work in an office environment
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 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
202.419.7762 or email@example.com to request
If you've ever wondered what's within you, there's no better
time to find out.
Keywords: Danaher, Sunnyvale , Senior Quality Systems Specialist, Other , Sunnyvale, California
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