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Product Surv Quality Assoc I

Req #: 180002D2_en
Location: Medina, NY US
Job Category: Quality
Date Posted: 1/23/2018 7:59:41 PM
Baxter International


About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.



This position is responsible for Regulatory Reporting, including final reportability determination or reportability review and/or processing Medical Device Reports, FARs, or BPDRs. 



Essential Duties and Responsibilities



  • Assisting in managing daily work assignments and workflows for reportability decision trees and Regulatory Reports to ensure on time reporting
  • Completing and documenting reviews of reportability decisions for accuracy. Responsible for final reportability determination, and/or:
  • Completing (performing peer review and submission) of Regulatory Reports. Responsible for accuracy and congruency of the MDRs, FARs or BPDRs.
  • Assessing investigation results for content related to Regulatory Reports and management of escalations to other functions
  • Managing a workflow of Regulatory Reports and monitoring timely submissions
  • Partnering with clinicians or with product owners to understand input needed for reportability determination
  • Participating in continuous improvement efforts and projects, including NCRs/CAPAs
  • May perform other Postmarket activities as assigned


Qualifications for this role

  • Ability to prioritize and multitask.
  • Proficient with computers.
  • Ability to work with cross-functional teams to interact effectively with peers, management and customers.
  • Readily accepting of assignments to new/different products.
  • Strong critical thinking and problem solving skills
  • Ability to work independently
  • Solid written/verbal communication skills
  • Strong interpersonal skills.
  • Detail oriented.
  • Customer focused.

Education and Experience

  • Minimum of an Associate’s Degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN) or equivalent experience (defined as a minimum of 3 years of medical products industry experience).  Bachelor degree and/or clinical certification (MT, RN) preferred
  • 0-3 years work experience in a cGMP related industry or in a clinical setting
  • Experience with process improvement initiatives and projects preferred


A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.


Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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