Principal Quality Engineer

3 days ago Be among the first 25 applicants

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. Our founding belief in 1931 continues to be our guiding principle as we redefine healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. We drive efficient and effective operations, holding each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

• Participate on product development teams to improve current marketed products and transfer the design to manufacturing.
• Participate in risk management activities (quality planning, product and process risk assessment, risk management), review and approval of process and product validation protocols and reports, review component qualifications, and develop and validate test methods.
• 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, identify test methods and sampling plans, and assist with designing inspection fixtures, ensuring measurement systems are capable using MSA where applicable.
• Partner with manufacturing on quality‑related process improvement projects, lean manufacturing projects, and equipment qualification/validation, reviewing and approving protocols and reports.
• Investigate, analyze, review, and report on product complaints (field events).
• Participate in and lead process improvement teams to implement quality improvement activities using Lean and Six‑Sigma methods.
• Lead the site 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 externalophageal suppliers (injection molding, stamping, and medical assembly).
• Own nonconformances and CAPA records.

• B.S. degree in Engineering or related scientific discipline. ASQ CQE certification is required if the degree is not in engineering.
• 8–10 years of experience in quality and/or product development.
• 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.
• Track record of leading large or complex projects and diverse teams.
• Working knowledge of FDA Quality System Regulations, ISO‑13485, and ISO‑14971.
• Proficient MS Office skills including MS‑Project and Visio.
• Ability to read and interpret design prints.
• Advanced technical degree preferred.
• ASQ Certification in Quality Engineering and/or Auditing highly desirable.
• Prior supervisory experience.
• Microbiology and sterilization validation experience highly desirable.
• Experience with biological products and/or chemical processing highly desirable.
• Previous quality auditing experience desirable.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees and strive to be transparent with our pay practices. The estimated base salary for this position is $104,000–$143,000 annually. Individual pay is based on location, skills, and experience. This position may also be eligible for discretionary bonuses.

For questions about pay philosophy and benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Applicants must be authorized to work for any employer in the U.S.; we are unable to sponsor or take over sponsorship of an employment visa at this time.