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Manager Quality Systems and Compliance

Req #: 1800045T_en
Location: St Paul, MN US
Job Category: Quality
Date Posted: 2/21/2018 3:39:11 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.

  • Lead the activities of the Quality System and Compliance department in the Quality organization. Responsibilities include oversight of document control, change control, quality related training, CAPA, complaint management for 2 sites. 
  • Responsible for coordination of quality system management review and internal / external audits.  
  • Responsible for results in terms of product quality and conformance to regulations and Baxter quality policies. 
  • Leads the activities of the Quality System and Compliance department in the Quality organization with responsibility for results in process quality.
  • Implements the quality system procedures to the site and manages compliance.
  • Responsible for strategy and implementation of the internal audit
  • Understands and assures conformance to regulations and Baxter quality policies applicable to the site. Interfaces with regulators during inspections.
  • Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
  • Leads quality management reviews and, develops and manages metrics
  • Interacts frequently with internal supervisors, functional peer and senior management
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
  • Works closely with Manufacturing in areas of GMP compliance
  • Develops budget for the department and ensures adherence to the budget.
  • Manages coaching, training and development of subordinates.


  • Thorough knowledge of applicable procedures, specifications, FDA QSR regulations and ISO standards.
  • Excellent people and organizational skills, Ability to manage/coach/supervise a team
  • Strong analytical and problem solving skills.
  • Strong communication and leadership skills.
  • Strong interpersonal/communication/influencing/negotiation skills
  • Strong project management skills.
  • Experience with inspections by the FDA & Certified Body
  • 5 – 8 years of manufacturing experience.
  • Lean manufacturing background, preferred.
  • Six Sigma background, preferred.
Education & Experience
BS in science or engineering or equivalent professional experience. 7+ years experience in Quality, Manufacturing, Engineering or related field which should include 3-5 years of supervisory experience

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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