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Quality Assoc II

Req #: 180001NQ_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 1/23/2018 7:29:45 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 to the manufacturing facilities and Quality Engineering teams performing complaint investigation, as well as identifying, assessing, and working to correct regulatory and quality risks.

  

Essential Duties and Responsibilities

  • Preforming reviews and approvals of complaint investigations for quality and accuracy

  • Identifying process improvements and driving improvements

  • Coaching manufacturing plants and investigation sites on performing investigations

  • Participating in and/or leading projects.

  • Creating and/or analyzing operations metrics and reports to identify improvement opportunities.

  • Developing plans to investigate identified risks and implement corrective action plans (CAPA), as assigned.

  • Proactively analyzing PostMarket surveillance data to drive actions or improvement opportunities

  • Facilitating governance for complaint investigations

  • Supporting activities related to integrating PostMarket surveillance data into risk management

  • 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, including qualification for the site investigators.
  • 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 (Engineering preferred)
  • 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.

A Career That Matters
 
 

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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