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Complaints Investigator - Medical Devices

Company: Agilent Technologies
Location: Cedar Creek
Posted on: May 16, 2020

Job Description:

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 requirements.
* 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 meetings.
* 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 overall capability.
* 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.



Required Qualifications:


* Bachelor's degree in Biological Sciences or equivalent (Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry, or other similar degree)
* Some laboratory benchwork experience

Desired Qualifications


* 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



EEO Statement

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 job_posting@agilent.com. EOE AA M/F/Vet/Disability/Sexual Orientation/Gender Identity.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Keywords: Agilent Technologies, Austin , Complaints Investigator - Medical Devices, Healthcare , Cedar Creek, Texas

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