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Baxter Logo Baxter · Quality Control

Quality Specialist, Complaints

United States, Skaneateles Falls Employment contract 68000.00 - 93500.00 USD / Year · Job Posted June 30, 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

  • Perform documented customer complaint investigations in accordance with FDA 21 CFR Part 820 and ISO 13485 requirements
  • Apply structured root cause analysis methodologies to identify nonconformities
  • Document complaint investigations clearly and accurately
  • Collaborate cross-functionally with Manufacturing, Engineering, Quality Assurance, and Regulatory Affairs
  • Draft clear and compliant customer response letters
  • Support the development and maintenance of the Quality Management System (QMS)
  • Support regulatory compliance activities
  • Assist in the planning and execution of internal and external quality audits
  • Support change control, risk management, and CAPA processes
  • Contribute to quality systems training activities
  • Demonstrate strong cross-functional communication and accountability
  • Comply with EHS, GMP, and regulatory requirements

Requirements

  • Bachelor's degree required
  • 0-2 years of experience in quality assurance, manufacturing or documentation
  • Experience with quality management systems, including experience in implementing and maintaining QMS
  • Strong knowledge of quality management systems (e.g., ISO 13485, FDA QSR) and regulatory requirements
  • Strong communication and interpersonal skills, including experience in working with cross-functional teams
  • Strong analytical and problem-solving skills, including experience in identifying and resolving quality issues
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and quality management software

Nice to have

  • Experience in a medical device manufacturing environment
  • Familiarity with quality control tools and methodologies (e.g., Six Sigma, Lean)
  • Quality systems certification, such as CQIA or CQE

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)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • 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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