Principal Eng, Quality Assurance

6 months 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.

Essential Duties and Responsibilities:
- Responsible for supporting and sustaining Quality Engineering activities related to medical device hardware and software.
- Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
- Assist in decision making for process improvement efforts.
- 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.
- Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
- Support Risk Management activities for NPD and sustaining engineering projects.
- Support post market activities such as complaint investigation, complaint trending, CAPA, and FA processes.
- Support global manufacturing facilities and associated manufacturing and supplier changes.
- Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries.
- Review and approve specifications, procedures, qualification/verification/validation protocols and reports, test cases and related documentation.
- Conduct audit and provide input to continual improvement.

Qualifications:
- BS engineering and 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.
- Good interpersonal/communication/influencing/negotiation skills.
- Good analytical and problem solving skills.
- Working knowledge of FDA Regulations.
- Demonstrated ability to lead others in project or investigational environments.
- Good technical overview of medical device verification, validation and test automation.
- Good understanding of 21 CFR Part 820, ISO 13485, EU MDD / EU MDR.
- Broad working knowledge of Medical Device Software Development Lifecycle and IEC 62304.
- Good 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.

**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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