Sr Eng, Quality AssuranceReq # JR - 030612 Location Bengaluru, Karnataka Job Category Quality Control Date posted 11/26/2020
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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.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis;sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Under direction of supervisor, responsible for supporting new product development and sustaining Quality Engineering activities related to medical device hardware.
• Job Title – Sr Eng, Quality Assurance
• Location – Whitefield, Bangalore
• Shift – General
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 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 FCA processes
- Assist in decision making for process improvement efforts
- 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 (Mechanical or Electrical engineering preferred) and 4-10 years in related Quality or Engineering field in the medical products industry.
- ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred 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 and validation
- Good understanding of FDA QSR Part 820, ISO 13485, EU MDD / EU MDR
- Broad working knowledge of Medical Device Software Development Life cycle and IEC 62304
- Basic 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.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
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.