Qa R&D Engineer
1 giorno fa
col-wideJob Description:
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.
Summary
Covering this position, you'll have the opportunity to implement Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for chronic and acute blood sets disposables, based on the project assignments received by the Product Quality Manager.
You'll also participate directly to projects for continuous improvement of product quality handling design NCR/CAPA (as quality approver).
What you'll be doing
Be a member of Project Core teams for New Product Development Projects and design Change Controls as Product Quality representative.
Performs Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for chronic and acute blood sets disposables, based on the project assignments received by the Product Quality Manager.
Review the documents for Device History File issuing and maintenance.
Assure compliance to all applicable Baxter corporate procedures as well as all local work instructions and applicable laws and standards.
Ensures that complaint data and CAPA corrective actions from current products are considered in sustaining engineering activities.
Quality approver of design NCR/CAPA for the product families assigned.
Collaborate and support other Company entities for Audits (internal and external) preparation.
Periodically reporting to Product Quality Manager about the status of activities under his/her responsibility.
What you'll bring
Degree in Engineering in the Biomedical field or Life sciences (Chemistry, biology…)
Previous experience in the Med-Tech industry with focus on medical devices
Knowledge and experience of Quality System based on ISO 13485, FDA, CFR, GMP regulation and MDSAP
Knowledge of Design Control and Risk Management principles
Critical thinking, problem-solving, collaboration, communications and negotiation skills are required
Proficient knowledge of English
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