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Product Surv Quality Assoc II

Req #: 180001ND_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 1/23/2018 6:32:04 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 processing high risk complaints and managing escalations. This position also serves as subject matter expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting.


Essential Duties and Responsibilities

  • Serves as a Subject Matter Expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting.
  • Assisting in managing daily work assignments and workflows for reportability decision trees and Regulatory Reports to ensure on time reporting. May be responsible for distributing daily assignments to assigned team.
  • 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
  • Analyzing PostMarket surveillance MDRs information to identify escalations or improvement opportunities
  • Leading and/or participate in cross functional continuous improvement activities and projects, including NCRs/CAPAs.
  • Leading mentoring and training of the PostMarket Surveillance team.
  • May interface with regulatory agents or internal auditors.
  • May perform other Postmarket activities as assigned


Qualifications for this role

  • Strong knowledge of the FDA Quality System and Regulatory Reporting regulations (21 CFR 803, 806, 820, and 211)
  • Ability to perform all duties required of previous levels
  • Strong interpersonal skills
  • Readily accepting of assignments to new/different products
  • Ability to prioritize multiple tasks
  • Ability to lead people and encourage teamwork
  • Customer focus
  • Ability to drive decisions quickly and effectively
  • Proficient with computers
  • Excellent written/verbal communication and organizational skills
  • Ability to effectively communicate across multiple levels within the organization
  • Ability to make independent decisions with minimum oversight and ability to work independently
  • Strong problem solving, critical thinking and analytical skills
  • Detail oriented

Education and Experience

  • Bachelor’s degree (life sciences preferred) or clinical certification (MT, RN) or equivalent experience (defined as a minimum of 5 years of medical products industry experience)
  • 2-5 years relevant work experience in cGMP related industry or in a clinical setting.
  • Experience with driving process improvement initiatives and projects preferred
  • Application of lean principles 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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