Complaint Handling Lead
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 someone of high caliber talent who has established
themselves as an expert in Complaint Handling and reporting to FDA
and other regulatory authorities in the area of medical
devices/IVDs. This role will be hands-on and will also have an
opportunity to manage employees involved in the investigation,
processing, and closing of complaints as well as facilitating MDR
and vigilance reporting, providing input to metrics, and ensuring
timelines for reporting are met for products manufactured by
You will work closely with Agilent's Quality and Regulatory teams
as well as the Field Service Engineers, Product Support, Research &
Development, and manufacturing organizations to ensure complaints
are thoroughly investigated.
Specifically, you will:
* Develop, manage, and maintain a product-specific complaint
investigation team including the hiring, training, and
* Participate in the development and maintenance, in collaboration
with product subject matter experts and medical affairs, product
failure modes for consistent reporting, trending, and identified
user and patient safety decisions.
* Ensure complaints are investigated, addressed, and closed in a
globally compliant manner which includes, when needed, the
coordination of manufacturing and/or R&D complaint
investigations with businesses.
* Ensure complaints are assessed for global reportability and MDRs,
Vigilance and similar reports are submitted to Regulatory
Authorities on time.
* Coordinate and provide input into trends and metrics ensuring
management is aware of any negative trends. Support the business,
as requested, when improvements are needed to correct negative
* Escalate complaint issues as they arise. Support businesses when
potential field actions and/or recalls are identified.
* Other tasks as assigned to support the business goals and
* Bachelor's degree in Biological Sciences or equivalent in
Biomedical Engineering, Systems Engineering, Pharmacology,
Chemistry, or other similar degree
* 8 years of relevant experience in diagnostic, medical devices
and/or pharmaceutical industry complaint management.
* Previous employee management skills desirable
* Knowledge of medical device/IVD regulations such as FDA CFR 21
Part 820, Part 803, Part 806 and ISO13485, ISO 14971, EU MDR,
* Team player who works effectively with teams across different
businesses, functions, and geographies.
* Demonstrated interpersonal and English communication skills.
* Strong root cause analysis and statistical capabilities.
* Experience in global diagnostic regulations, Oracle Agile
software, SAP CRM, SAP Quality Module and/or similar systems
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
email@example.com. 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 , Complaint Handling Lead, Other , Cedar Creek, Texas
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