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Manager II Quality Assurance Solutions

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Baxter

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Location:
United States , Cleveland

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

136000.00 - 170000.00 USD / Year
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Job Description:

As the Manager II, Quality Assurance - Solutions, you will lead all aspects of Devices Quality operations and manage staff in this area. You will direct, coordinate, and evaluate the unit's work, ensuring activities follow company policies and legal requirements. You will also lead initiatives to improve processes and maintain compliance with standards, ensuring our products meet quality expectations.

Job Responsibility:

  • Lead quality oversight for the Devices areas
  • Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
  • Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
  • Ensure product compliance through established inspection criteria and procedures
  • Coordinate inspection activities throughout the production cycle
  • Analyze statistical data and product specifications to determine and improve quality standards
  • Prepare and submit reports to Managers and other Departments or Agencies as required
  • Communicate quality philosophy to key personnel
  • Actively participate in quality management teams within the organization
  • Manage and support area associates, encouraging a teamwork environment
  • Train and integrate new engineers, associates, and technicians
  • Drive quality/manufacturing projects using Lean, problem-solving, process control, and project management tools
  • Maintain comprehensive knowledge of plant systems, processes, procedures, documentation, and products
  • Evaluate and implement system changes per Baxter procedures
  • Lead and establish effective working teams
  • Manage and prioritize multiple tasks and projects
  • Ensure effective communication in both written and verbal forms
  • Coordinate financial goals and budgets for departments
  • Promote company security, industrial hygiene, cGMPs, and other established policies
  • Perform tasks independently with minimal supervision
  • Travel as needed to fulfill duties

Requirements:

  • Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
  • 5+ years of Engineering/Manufacturing/Quality experience required
  • 3-5 years of leadership experience
  • FDA regulated manufacturing experience preferred
  • Six Sigma Green Belt Certification or industry-standard equivalent preferred
  • Project Management skills and experience are preferred
  • Experience and skills in Lean Manufacturing are preferred

Nice to have:

  • FDA regulated manufacturing experience
  • Six Sigma Green Belt Certification or industry-standard equivalent
  • Project Management skills and experience
  • Experience and skills in Lean Manufacturing
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

Additional Information:

Job Posted:
March 13, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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