Principal Quality Engineer

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. 

Your Role at Baxter!

The Principal Quality Engineer applies a solid understanding of theories/practices applied by other fields outside the primary area of expertise toward the development of new or enhanced products or Quality processes. The person in this role plans, implements and functionally advises important engineering assignments, which require independent judgment.

What you will be doing

• Applies innovative techniques in the area of expertise to develop new or improved products and processes
• May lead a large scale program or several small projects with sophisticated features
• Independently plans, schedules and leads cross-functional team in detailed phases of the Quality work in a project
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvement
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
• Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
• Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
• Take lead role in NCR/CAPA activities such as investigation, implementation, or verification of effectiveness
• Support risk management activities as they relate to product and post market surveillance.
• Provide product quality support on new product development, risk management, design transfer and sustaining engineering core team
• Work collaboratively with R&D to develop Product Design Requirement and & Test Methods for successful Design Verification and Validation
• Defend/support product design history file (DHF) in internal and external audits
• Provide PQ support to 510(k) submission, product launches, product recalls/field actions, NCRs and CAPA investigations

What do you bring

• B.S. degree in Engineering
• Minimum of 6 years’ experience in Quality, Manufacturing, Engineering or related field
• Demonstrated success in delivering results on several technical/product/Quality challenges
• ASQ and/or Six Sigma Blackbelt Certification preferred
• Product development experience with medical devices preferred
• Proficient in relevant products or process development processes (i.e. NPD and sustaining-life cycle management)
• Must have experience with crafting/managing Design History File (DHF) and Risk Management File (RMF)
• Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls
• Good project management skills
• Recognized as a technical expert by peers and other personnel within the business unit
• Extensive multi-functional team experience, including technical and non-technical work
• Ability to coordinate and present technical and project mgt. overviews without assistance
• Solid understanding of FDA Regulations (e.g. 21 CFR Part 820), Application of Good Laboratory Practices, Application of Good Manufacturing Practices, ISO (e.g. ISO13485 and ISO14971) and other applicable standards (e.g. IEC60601 and IEC62304 electromechanical medical device) and ISO 22442 (Med Devices using animal tissues) and regulatory requirements (e.g., EU MDD and MDR)

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