Principal Eng, QA

2 months ago

Bengaluru Karnataka, India BAXTER Full time

**Vantive: A New Company Built On Our Legacy**

Baxter is on a journey to spin off our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Under direction of supervisor, responsible for supporting and sustaining Renal Quality Engineering activities related to medical device hardware and software.

Essential

**Responsibilities**:

- 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.
- Provide support for Non-product SW tool validation.
- 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 8+ 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**

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