Principal Quality Engineer Job at Baxter (Saint Paul)

Principal Quality Engineer

Baxter

Location:
United States , Saint Paul

Category:
IT - Administration

Contract Type:
Not provided

Salary:

104000.00 - 143000.00 USD / Year

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Job Description:

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Job Responsibility:

Provide Quality Leadership and support to the value stream product teams for biological and/or mechanical microsurgery medical devices
Ensure proper product design and manufacturing process design and execution for such devices
Participate on product development teams to improve current marketed products and transfer of the design to manufacturing
Participate in risk management activities
Review and approval of process and product validation protocols and reports
Review component qualifications, and test method development/validation
Lead site initiatives to implement robust validation programs such as visual and mechanical in-process inspection programs, process validation, and test method validations
Set statistically valid inspection requirements, including identifying test methods and sampling plans and assisting with designing inspection fixtures
Assure measurement systems are capable using MSA, when applicable
Partner with manufacturing on quality related process improvement projects, lean manufacturing projects, and equipment qualification/validation, through review and approval of protocols and reports
Investigate, analyze, review and report on Product Complaints (Field Events)
Participate on and lead process improvement teams to implement quality improvement activities using Lean, and Six-Sigma methods
Be the site lead to implement systems and processes for global alignment
Lead or participate in Corrective and Preventive Actions (CAPA)
Ensure alignment of site processes to business-wide processes
Manage coaching, training and development of subordinates
Work with external suppliers (injection molding, stamping, and medical assembly)
Own nonconformances, Corrective and Preventative Action records

Requirements:

B.S. degree in Engineering, or related scientific discipline
8-10 years of experience in quality and/or product development
Job experience or advanced training and demonstrated proficiency in total quality management, statistical methods, qualification of injection molding tools, root cause analysis / resolution, risk analysis, SPC, MSA, and design of experiments
Experience in new product development, materials science, and biocompatibility
Excellent oral and written communication skills
Strong problem solving, technical writing, organizational, leadership, and interpersonal skills
Successful track record of leading large or complex projects and diverse teams
Working knowledge of FDA Quality System Regulations, ISO-13485, and ISO-14971
Technical writing skills
Proficient MS Office skills including MS-Project and Visio
Must have the ability to read/interpret design prints
ASQ CQE certification is required if 4-year degree is not in engineering

Nice to have:

Advanced technical degree preferred
ASQ Certification in Quality Engineering and/or Auditing is highly desirable
Prior supervisory experience
Microbiology and sterilization validation experience is highly desirable
Experience with biological products and/ or chemical processing is highly desirable
Previous Quality Auditing experience is desirable

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:
January 13, 2026

Employment Type:

Fulltime

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