Eng II, Quality Assurance

1 month ago

Bengaluru, India Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate 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.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Job Summary

Under direction of supervisor, responsible for supporting new product development and sustaining Quality Engineering activities related to medical device hardware.

Essential Duties and Responsibilities

Demonstrate quality assertiveness and can represent the Quality function in various roles such as product support and lifecycle management. Provide quality role support assisting in creating and maintaining Training Matrix, Tracking QMS metrics and Lab documentation and test plans is an added advantage. Provide support for evidences generation during audits or for any inquires FDA/ministry of health (MOH) inquiries. Support Purchase order approvals Support document management life cycles using PDLM tools such as (windchill, TcU and other Proprietary tools) Basic understanding of Non conformance and CAPA process.

Qualifications

BS engineering (Mechanical or Electrical engineering preferred) with 3 to 4 year experience. Or Diploma in Engineering or 3 years Graduation with 6 to 8 years in managing Training, Lab Controls, Purchase process. Strong interpersonal/communication/influencing/negotiation skills. Working knowledge of Regulations such as FDA or other ISO standards. Good understanding of Organization Support process (Training, HR, Purchasing and Lab management)

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