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Baxter Logo Baxter · Quality Control

Sr. Analyst, Quality Systems

United States, Saint Paul Employment contract · Job Posted July 14, 2026
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Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

  • Own and continuously improve the site Quality Management System (QMS)
  • Lead the implementation, administration, and ongoing effectiveness of Quality Systems
  • Drive document control excellence by authoring, reviewing, and approving controlled documents
  • Manage and enhance the training program
  • Ensure site-wide compliance readiness by coordinating internal and external audits
  • Lead Management Review processes
  • Own the Change Control process
  • Develop, monitor, and communicate Quality System metrics
  • Interpret and communicate QMS KPIs
  • Author, review, and continuously improve SOPs and controlled documents
  • Lead and deliver Quality Systems training
  • Initiate and own nonconformance records (NCRs) as needed
  • Plan and execute internal audits
  • Coordinate, host, and respond to external audits
  • Drive cross-functional collaboration to resolve compliance gaps
  • Lead or contribute to multi-site Quality projects
  • Supervise team members
  • Other duties, tasks or projects as assigned

Requirements

  • Strong verbal and written communication skills
  • Effective documentation practices
  • Ability to engage confidently across all levels of the organization
  • Drives continuous improvement of procedures and processes
  • Simplifies complexity, increases efficiency, enhances usability across Quality Systems
  • Interprets and applies quality system regulations
  • Ensures compliance
  • Translates regulatory requirements into practical, site-ready solutions
  • Maintains relevant professional certifications (e.g., CQA, ISO 13485 Auditor) or actively works toward certification
  • Fosters collaborative, team-oriented environment
  • Builds strong relationships
  • Influences others through effective interpersonal and leadership skills
  • Strong problem-solving and critical-thinking skills
  • High level of attention to detail
  • Ability to clearly communicate findings and recommendations
  • Manages projects effectively
  • Prioritizes work
  • Meets deadlines
  • Ensures successful execution of multiple concurrent initiatives
  • Working knowledge of FDA and ISO regulations, including ISO 13485 and 21 CFR 820
  • Consistent application of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
  • Bachelor's degree in science or engineering or other related field
  • Minimum of 5+ years of experience in Quality with emphasis on regulation and compliance, or related field in the medical device industry
  • Audit experience (as auditee or auditor) required

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP) with ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits
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