Engineer, Quality Complaint Investigations

at  Baxter

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

WHAT YOU’LL BE DOING

• This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks applying various quality system inputs!
• Review individual complaints and associated service data to determine risk level and complete investigation into the “as determined” problem code and cause codes for each complaint.
• Analyze data from various quality inputs (including but not limited to : Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues. Prepare and issue reports based on information analysis.
• Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
• Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.
• Observe and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
• Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation.
• Support CAPA and maintenance activities for existing product lines.
• Recommend and/or support projects for improvements to the quality system as approved by management.