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Quality Assoc II

Req #: 180001NS_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 1/23/2018 7:29:47 PM
Baxter International

Description

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.

 

Description

 

This position is responsible for providing Quality support and oversight as well as identifying, assessing, and working to correct regulatory and quality risks.

 

  

Essential Duties and Responsibilities

  • Preforming reviews of complaint files for quality and accuracy
  • Identifying process improvements and driving improvements
  • Coaching complaint handling team on complaint file documentation
  • Participating in and/or leading projects.
  • Creating and/or analyzing operations metrics and reports to identify improvement opportunities.
  • Leading and/or participating in cross functional continuous improvement activities and projects, including NCRs/CAPAs
  • Leading mentoring and training of the Product Surveillance team.
  • May interface with regulatory agents or internal auditors
  • May perform other Postmarket activities as assigned

As assigned:

  • Serve as a Subject Matter Expert.
  • Provide training and coaching.
  • Write, review, analyze, and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed

 

 

 

Qualifications

Qualifications for this role

  • Interpersonal skills
  • Verbal and written communication skills
  • Ability to effectively communicate across multiple levels within the organization
  • Self-motivated with the ability to work independently and make decisions Excellent organizational skills, critical thinking, problem solving skills and attention to detail
  • Ability to perform multiple tasks simultaneously and work cross-functionally in a highly-matrixed environment.
  • Ability to drive decisions and actions quickly and effectively.
  • Ability to manage people and encourage teamwork
  • Expertise in interpreting regulations and familiarity with GDP and GMP
  • Experience with working in an environment subject to compliance with 21 CFR Parts 803, 806, 810, 820 strong preferred.
  • Collaboration and Teamwork
  • Proficient with computers
  • Customer Focus

 

Education and Experience

  • BS in business or science or equivalent
  • 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.

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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