BAXTER is Hiring | Sr Eng, Quality Assurance |

Position – Sr Eng, Quality Assurance
BAXTER
Location – Bengaluru, Karnataka

Job description

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 a key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries

Qualifications

  • BS engineering (Mechanical or Electrical engineering preferred) and 4-10 years in related Quality or Engineering field in the medical products industry.

Skills

  • 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 a 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.

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