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Principal Eng, QA

Req # JR - 023700 Location Bengaluru, Karnataka, India Additional Locations 45 Job Category Quality Control Date posted 07/10/2020

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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

Under direction of supervisor, responsible for supporting and sustaining activities related to Medical Device hardware and software

Essential Duties and 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
  • Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
  • Support Risk Management activities for sustaining engineering projects.
  • Support post market activities such as complaint investigation, complaint trending, CAPA, and FA processes
  • Support global Renal manufacturing facilities and associated manufacturing and supplier changes
  • Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries

Qualifications

  • BS engineering and 8+ years in related Quality or Engineering field in the medical products industry.
  • ASQ (e.g., CSQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred
  • 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 or similar standards
  • Understanding and working knowledge of reviewing automated test scripts and tools such as ALM.
  • Strong interpersonal/communication/influencing/negotiation skills.
  • Strong analytical and problem-solving skills.
  • Working knowledge of FDA Regulations
  • Demonstrated ability to lead others within small project or investigational environments
  • Good technical overview of medical device verification, validation and test automation.
  • 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

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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