Complaints Investigator - Medical Devices
Company: Agilent Technologies
Location: Cedar Creek
Posted on: May 16, 2020
Agilent inspires and supports discoveries that advance the
quality of life. We provide life science, diagnostic and applied
market laboratories worldwide with instruments, services,
consumables, applications and expertise. Agilent enables customers
to gain the answers and insights they seek ---- so they can do what
they do best: improve the world around us. Information about
Agilent is available at www.agilent.com.
We seek a highly motivated individual eager to learn the Invitro
Diagnostics (IVD) industry and is looking for the opportunity to
work in a dynamic and progressive environment as a Complaint
Handling Investigator. This role is key to ensuring the quality of
products for our customers and help to identify early signs of
potential issues. This role is hands on and will be involved with
the intake, investigation, processing, and closing of complaints as
well as assessment for reportability to regulatory authorities,
providing input to metrics and ensuring timelines for processing
complaints are met. You will work closely with Agilent's Quality
and Regulatory teams as well as Field Service Engineers, Product
Support, Research & Development and Manufacturing organizations to
ensure complaints are thoroughly investigated.
Job Responsibilities include:
* Conduct complaint investigations, including intake, assessment of
reportability, investigation, and closure.
* Work with cross-functional team members during investigations
including, but not limited to, members from R&D, Manufacturing,
Technical support, Logistics, Field Service Engineers to help
determine root cause and corrective actions as needed.
* Support Management Review Board (MRB) and Corrective and
Preventive Actions (CAPA) meetings as needed.
* Record complete and accurate findings regarding each complaint
investigation, including the conclusion and any corrective actions
taken. Maintain complaint records as required by regulatory
* Communicate findings to technical services and management in
concise summary formats.
* Support the analysis, tracking and trending of complaints data on
a weekly and monthly basis for input at Technical and QA
* Participate and provide necessary records and support for
internal or external audits.
* Collaborate with co-workers to meet business objectives and
enhance team capability.
* Share knowledge and experience with co-workers to develop team's
* Works on other quality department assignments with broadly
defined objectives as assigned.
* Supports solution of non-routine issues, challenges, and problems
within field of specialization.
* Bachelor's degree in Biological Sciences or equivalent
(Biomedical Engineering, Systems Engineering, Pharmacology,
Chemistry, or other similar degree)
* Some laboratory benchwork experience
* Experience with data analysis and workflow troubleshooting
including instrumentation, arrays and biological materials
* Experience in Biotech and/or Pharma industry
* Awareness of ISO 13485 and QSR quality management system
requirements and IVD products
Agilent Technologies, Inc. is an Equal Employment Opportunity and
Affirmative Action employer. We value diversity at all levels. All
individuals, regardless of personal characteristics, are encouraged
to apply. All qualified applicants will receive consideration for
employment without regard to sex, pregnancy, race, religion or
religious creed, color, gender, gender identity, gender expression,
national origin, ancestry, physical or mental disability, medical
condition, genetic information, marital status, registered domestic
partner status, age, sexual orientation, military or veteran
status, protected veteran status, or any other basis protected by
federal, state, local law, ordinance, or regulation and will not be
discriminated against on these bases.
Agilent Technologies, Inc., is committed to diversity in the
workplace and strives to support candidates with disabilities. If
you have a disability and need assistance with any part of the
application or interview process or have questions about workplace
accessibility, please contact +1-262-754-5030 email
firstname.lastname@example.org. EOE AA M/F/Vet/Disability/Sexual
For more information about equal employment opportunity
protections, please see all of our notices for EEO below.
Equal Opportunity Employer Minorities/Women/Protected
Keywords: Agilent Technologies, Austin , Complaints Investigator - Medical Devices, Healthcare , Cedar Creek, Texas
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