Senior Principal Quality Engineer - Advanced Surgery
Overview
Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide.
-
Support for Parents
-
Continuing Education/ Professional Development
-
Employee Heath & Well-Being Benefits
-
Paid Time Off
-
2 Days a Year to Volunteer
Success Profile
What makes a successful Engineer at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Problem Solver
- Analytical Thinker
- Data Driven
- Solution Focused & Results Oriented
- Collaborative
- Innovative
Senior Principal Quality Engineer - Advanced Surgery
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 at Baxter!
- Applies innovative techniques in the areaofexpertise 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 thedevelopmentof 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 designhistoryfile(DHF) in internal and external audits
- Provide PQ support to 510(k) submission, product launches, product recalls/field actions, NCRs and CAPA investigations
- B.S.degree in Engineering
- Minimumof8years’experience in Quality, Manufacturing, Engineering or related field
- Demonstratedsuccess 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/managingDesignHistoryFile(DHF) and Risk Management File (RMF)
- Demonstrates leadershipskills 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
- Solidunderstandingof FDA Regulations (e.g. 21 CFR Part 820), ApplicationofGood Laboratory Practices, ApplicationofGood 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)
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.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Address
Deerfield, IL 60015
United States of America Explore This Location
Related Content
-
March 05, 2024
-
Employee Benefits Our comprehensive benefits options reflect the value we place in our employees. March 28, 2024
-
People of Baxter The people of Baxter are men and women who make a difference at work and in their communities. March 28, 2024
-
March 05, 2024
-
March 05, 2024
-
How to Apply Learn tips to better prepare yourself for the application process. March 05, 2024 Related Content - SR_JD
-
March 05, 2024
-
March 05, 2024
-
June 14, 2024
-
June 14, 2024
-
June 05, 2024
-
May 07, 2024
-
Change Creates Opportunity We believe change provides the opportunity to push beyond what we thought we were capable of achieving. April 29, 2024
-
July 11, 2024
-
May 31, 2024
-
May 01, 2024
-
Meet Mike Hear from Mike Demirjian on how change is necessary for growth, innovation, and improvement. May 01, 2024
-
May 08, 2024
-
July 15, 2024
-
July 14, 2024
-
July 09, 2024
-
July 15, 2024
-
May 08, 2024
-
July 15, 2024
-
May 01, 2024
-
May 07, 2024
-
July 14, 2024
-
July 14, 2024
-
July 12, 2024
-
July 11, 2024
-
July 10, 2024
-
July 12, 2024
-
July 12, 2024
-
July 11, 2024
-
April 29, 2024
-
July 11, 2024
-
July 15, 2024
-
July 14, 2024
-
July 13, 2024
-
July 13, 2024
-
July 13, 2024
-
July 09, 2024
-
July 10, 2024
-
July 09, 2024
-
Our Proposed Separation We plan to separate our Kidney Care Global Business Segment from Baxter to become a separate company. Discover what this means for you. May 03, 2024 Related Content - SR_JD
-
May 23, 2024
-
July 11, 2024
-
Meet Yukinari Yukinari Kono believes a leader should instill confidence and optimism in his teams during times of transformation. May 08, 2024
-
Career Areas Explore our various career sectors and uncover the one that aligns best with your talents and professional goals. March 05, 2024 Related Content - SR_JD
Join Our Talent Community
We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.