Complaint Handling Lead

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 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 Agilent.

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 compliance.
* 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 trends.
* 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 objectives






* 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, IVDR.
* 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 preferred.





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.

https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf,

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Keywords: Agilent Technologies, Austin , Complaint Handling Lead, Other , Cedar Creek, Texas