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