Principal Eng, Quality Assurance

2 weeks ago

Bengaluru Karnataka, India BAXTER Full time

**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.

Job Description:
- This Principal Engineer, Quality Assurance position falls within a growing team for Software Quality. This person will work as a member of one or more cross-functional product development teams by being engaged in new product development and/ or sustaining products covering emerging technologies such as Digital Health, Health Software, Software as a Medical Device (SaMD) and Clinical Decision Support (CDS). This individual will serve as a quality representative on the software project team and will work closely with the Core Team Leader. This role is responsible for ensuring that each project is developed and released meeting customer expectations and in compliance with Baxter’s software lifecycle management policies and procedures. This Principal Engineer will work closely with product engineering to ensure robust requirements, successful design, development, verification and validation testing, design transfer and change control management. In addition, this individual will provide support to product software sustaining engineering and support the creation of regulatory submission documentation.

Qualifications:
- Bachelor’s degree in engineering or computer science with a minimum 10 years of experience in a highly regulated industry such as FDA, DoD, aerospace or telecom with a thorough understanding of the regulations, standards, Software Development Life Cycle (SDLC) and quality management systems.
- Experience in assessing and developing procedure to meet Digital Health regulatory requirements and guidance’s.
- Experience with FDA inspections. ISO/ Notified Body audits is a plus.
- Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification. ASQ CSQE preferred.
- Strong communication and leadership skills.
- Strong, results driven, project management skills.
- Excellent problem-solving skills and the ability to teach others.
- Capable of clearly presenting and justifying quality position and requirements to management.
- Hands-on Experience on Software development is added Advantage.

**Reasonable Accommodations**

**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.

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