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Principal Quality Engineer

4 weeks ago

Skaneateles Falls NY, United States BAXTER Full time

At Baxter, we are deeply connected by our mission. 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.

Responsible for compliance, validation and providing Quality guidance for process/area responsibilities. 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.
Within Quality Ops, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. This open dialog builds trust within the team and helps create a better product for our customers.
Organize, review, and perform computer system validation or other software validation related evaluations to support the Master Validation Plan. Support the data integrity initiatives to relevant systems, processes, and equipment.
Evaluate all relevant operational data, reports, statistics, and documentation related to manufacturing process and product performance and product quality, to generate proactive and timely actions when needed to address a quality issue or improve a process.
Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes. Drives quality and manufacturing improvements to ensure our processes are in state of control.
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). Assist in complaint/field return investigations related to manufactured product. Lead product complaint trending monthly for responsible areas. Analyze returned components, recommend corrective actions, and follow-up on multi-functional team responses and implementation of corrective actions.
Lead process improvement projects (scrap reduction, defect reduction, etc.) Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation for responsible areas. Provide guidance to other Quality Engineers for their designated areas as required.
Minimum of a BA or BS in Engineering with a minimum of 7+ years related experience, or 4+ years related experience w/ an advanced degree or proven performance and increasing responsibility within Quality roles.
Strong scientific analysis and troubleshooting skills
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
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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. 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.


Pay Transparency Policy

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.


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