QA Operations Supplier Engineer
2 mesi fa
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.
The QA Operations Supplier Engineer supports the manufacturing plant activities related to identification, investigation and resolution of nonconformances originated from suppliers. Main duties and responsibilities for the role are:
To collect all necessary information and data associated to identified supplier nonconformances; To conduct the necessary assessments, investigations and analyses to confirm potential root causes sitting in supplier processes; To act as SCAR owner according to applicable QMS; To interact with supplier to inform about observed nonconformances, to issue SCARs, to monitor and follow-up on necessary responses and feedbacks useful for the resolution of quality issues from the external entities; To collect and to track supplier containments, corrections and corrective actions implemented; To define and conduct the necessary strategies to confirm effectiveness of supplier actions; To conduct statistical data analysis and trending to ensure proper monitoring of supplier related problems.Requirements
The function requires a University degree in technical/scientific area, Engineering is preferred. Experience of 3-5 years in medical industry, in Quality/R&D function. Previous experience in roles with strong connection to supplier processes is preferred. Operative Knowledge of Quality System based on ISO 13485, FDA CFR, GMP regulations and MDSAP (including related regulations) is preferred Good communication and negotiation skills Teamworking approach Fluency in English, written and spoken#LI-CG1
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