Quality Systems Specialist

Baxter•St Paul, MN

About The Position

The Quality Systems Specialist supports and strengthens Baxter’s Quality Management System, ensuring compliance with global regulatory and industry standards. The role provides quality oversight and guidance for quality system processes, investigations, audits, and product release activities, and works across manufacturing, engineering, regulatory affairs, and supplier quality teams. The position contributes to operational excellence, regulatory readiness, business continuity, and the delivery of safe, high-quality products.

Requirements

Bachelor’s degree in Engineering, Quality, Life Sciences, Microbiology, Chemistry, or a related technical field, or an equivalent combination of education and directly related experience in a regulated manufacturing environment.
5+ years of experience supporting quality systems in the medical device, pharmaceutical, biotechnology, or combination product industries.
Experience managing CAPAs, nonconformance investigations, change controls, audit activities, and continuous improvement initiatives.
Strong knowledge of FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, and quality risk management principles.
Ability to conduct investigations, analyze data, solve complex problems, and communicate recommendations effectively across functions.
Strong technical writing, documentation review, organizational, and project prioritization skills.
Ability to travel up to 10% as needed to support audits, remediation activities, and multi-site quality initiatives.
Must be authorized to work for any employer in the U.S.; visa sponsorship or transfer is not available.

Nice To Haves

Lead Auditor certification or demonstrated experience supporting internal, external, customer, or regulatory audits.
Experience supporting multiple manufacturing sites within a regulated environment.
Familiarity with electronic Quality Management Systems (eQMS), including TrackWise, Adobe approval workflows, and ERP platforms.
Experience supporting product release and product complaint processes.
Ability to work independently, manage competing priorities, and influence stakeholders across organizational levels.

Responsibilities

Lead quality review and approval of change control records, ensuring risk assessments, supporting evidence, and implementation plans meet quality requirements.
Own and coordinate nonconformance investigations and Corrective and Preventive Actions (CAPAs), driving timely root cause analysis and sustainable corrective actions.
Partner with cross-functional teams to resolve quality issues, improve processes, and maintain compliance with regulatory and corporate quality standards.
Review manufacturing, inspection, and release documentation to support product disposition decisions and ensure products meet quality requirements before release.
Support internal, customer, regulatory, and notified body audits by preparing documentation, gathering evidence, and contributing to successful audit outcomes.
Monitor quality system performance metrics, identify trends and risks, and proactively escalate issues that could affect compliance, product quality, or business operations.
Serve as a quality systems subject matter expert, supporting document control, procedural updates, and continuous improvement initiatives across multiple sites.

Benefits

Medical and dental coverage beginning on day one
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan with employee contributions and company matching
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
Childcare benefits
Potential eligibility for discretionary bonuses