Sr 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.
Summary
Provide Quality Systems Leadership for biological and/or mechanical medical devices. Lead impactful projects to improve quality systems across functional areas. Functions include manufacturing, product design, and regulatory. In addition, this position will lead Internal/External audits.
Essential Duties and Responsibilities
Lead cross-functional site initiatives to harmonize quality systems with Baxter policies and procedures
Lead EU-MDR (2017/745) implementation for local quality system
Lead continuous improvement initiatives across quality system elements
Lead both internal and external audit processes, including training and readiness activities
Establish Quality System dashboards to monitor overall health of quality system
Participate on and lead process improvement teams to implement quality improvement activities using Lean, and Six-Sigma methods
Support site integration activities of other sites into one Quality System
Qualifications:
Required
B.S. degree in Engineering, or related scientific discipline. ASQ CQE certification required if 4-year degree is not in engineering
8-10 years of experience in quality and/or product development
Job experience or advanced training and demonstrated proficiency in total quality management, statistical methods, quality tools, root cause analysis / resolution, risk analysis, SPC, MSA, and design of experiments
Excellent oral and written communication skills
Strong problem solving, technical writing, organizational, leadership, and interpersonal skills
Demonstrated Critical Thinking skills with focus on improved performance outcomes and positive business impact
Successful 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
Preferred:
Advanced engineering or technical degree preferred.
ASQ Certification in Quality Engineering and/or Auditing is highly desirable.
Computer systems validations & process validation experience highly desirable.
Experience with mechanical and biological products, and/ or chemical processing highly desirable.
Prior supervisory experience.
Previous Quality Auditing experience is desirable.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
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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