Principal Quality Engineer

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.

Your Role This is where your expertise helps people Responsible for compliance, validation and providing quality guidance for process/area responsibilities. Responsible for the execution and completion of several open projects across Quality Systems. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.

Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective / preventative action philosophies and strategies. Your Team We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment.

Together, we build and maintain a positive work environment. As a Principal Quality Engineer, you will have the opportunity to lead, and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow.

What Youll Be Doing • Lead compliance improvement projects to meet deadlines and document results for closure. Responsible for 3 - 5 key projects open at one time. • Lead several activities for the site across several chapters of the Quality Management System. • 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 determining 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. • Host cross-functional meetings to provide executive summaries and report outs on project status, gaps, integration, and other metrics. • Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics. Document such actions within the quality system as appropriate (NCR/CAPA). Apply standard operating practices and problem-solving methodology. • Lead process improvement projects with no or little guidance. • Ability to provide requirements for change control based on procedural requirements.

What Youll Bring • Minimum of a BA or BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience e.g. education or employment in sciences or validations) with a minimum of 7 years, or 4 years related experience with an advanced degree or proven performance and increasing responsibility within Quality roles. • Six Sigma black belt or ASQ CQE certification desirable. • Prior experience interacting with the FDA and other regulated industries is a must. • Ability to work effectively with multi-department and multi-site teams • Ability to manage and organize complex technical problems • Good written and oral communication skills, excellent attention to details • Strong team leader with management skills and focus on results • Strong scientific analysis and troubleshooting skills • Meet deadlines & influence decisions cross-functionally • Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes 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 we strive to be more transparent with our pay practices. The estimated range is meant to reflect an anticipated salary range for the position.

We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

For questions about this, our pay philosophy, and available 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.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic