Position – Sr Eng, Quality Assurance
Location – Bengaluru, Karnataka
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
- 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 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.