Senior Engineer, Quality Assurance Bengaluru, Karnataka

Job description

Keywords Location Radius Senior Engineer, Quality Assurance Req # 211436 Location Bengaluru, Karnataka, India Job Category Quality Date posted 10/13/2026 Apply Now Overview This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. Support for Parents Continuing Education/ Professional Development Employee Health & Well-Being Benefits Paid Time Off 2 Days a Year to Volunteer Success Profile What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. Detail Oriented Continuous Learner Courageous Collaborative Critical Thinker Influential Senior Engineer, Quality Assurance Apply Now This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter Under direction of supervisor, responsible for supporting new product development and sustaining Quality Engineering / Assurance activities related to medical device hardware and software. What you’ll be doing Ensures that activities within the Product Development elements are performed in a manner consistent with the Design and Development Plan, Change Plan and Quality Planning. Responsible for Quality Assurance of the Product Development and Lifecycle Management process. Responsible for the compliance and approval of PDLM records to Baxter procedures throughout the product lifecycle. Collaborate with regulatory affairs as needed to guide teams in meeting quality/regulatory requirements based on the regulatory plan/strategy or assessment. Collaborate with teams to provide guidance for meeting Baxter Requirements and External Quality Standards as appropriate. Compliance of the Risk Management File. What you’ll bring BE/Master's or Equivalent in Engineering or Equivalent field with 6-10 years in related Quality or Engineering field in the medical products industry. ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred Strong interpersonal/communication/influencing/negotiation skills. Strong analytical and problem-solving skills. Working knowledge of FDA Regulations Demonstrated ability to lead others within small project or investigational environments Good technical overview of medical device verification and validation Good understanding of FDA QSR Part 820, ISO 13485, EU MDD / EU MDR Broad working knowledge of Medical Device Software Development Life cycle and IEC 62304 Basic understanding of medical device manufacturing process Good Understanding of requirements for Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation. 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. 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 . Apply Now Address Explore this location Tower B, 16th Floor Karnataka- 560 048 Karnātaka India Explore This Location Share LinkedIn Facebook X Email Hear from Our Employees Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world. Meet Christelle, Senior Quality Manager in Malta “I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.” Meet Lorena, Senior QA Associate in London, UK “I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.” Meet Gary, Quality Research Manager in Singapore “I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.” Related Content Employee Benefits Our comprehensive benefits options reflect the value we place in our employees. Learn More March 28, 2024 People of Baxter Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world. These are our stories. Learn More March 28, 2024 Read Time: 5 min. Our Stories - Hub Employee Stories Article Meet Yukinari Kono, GM of Kidney Care Japan Yukinari Kono, GM of Kidney Care Japan, leverages sales, marketing, and finance expertise to drive success and inspire team confidence. Learn More June 14, 2024 Baxter Manufacturing in Skaneateles Falls, NY The Skaneateles Falls Site is a leading manufacturer of medical devices and solutions, with a focus on Laryngoscopes, Ophthalmoscopes, Otoscopes, Stethoscopes, Vital Signs Monitors, Diagnostic Wall System, Blood Pressure Cuffs, and more. Learn More July 14, 2024 Read Time: 5 min. Our Stories - Hub Location Highlights Article Research & Development | Careers at Baxter At Baxter R&D, where your work directly impacts patient outcomes worldwide. We offer opportunities for software engineers, project managers, researchers, engineers, and technicians to collaborate on innovative solutions that Save and Sustain Lives. Work in a culture that values knowledge-sharing, mentoring, and cross-functional teamwork. Learn More May 01, 2024 Baxter Site in Guyancourt, France The Guyancourt site is Baxter's Commercial HQ in France, serving Sales & Marketing, Customer Support, Clinical Education, and Supply Chain functions.