Quality Engineer Job in Bengaluru at Becton Dickinson Private Limited

Becton Dickinson Private Limited is hiring for the role of Quality Engineer!

Responsibilities of Candidate:

•  Participates in design control activities of medical device products. Ensures proper design and development control and its documentation as per ISO 13485/ FDA QSR Quality System. 
• Leads or supports Risk Management in accordance with ISO14971. 
• Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, and professional manner.
• Creates, implements changes to, and maintains controlled documents as needed (e.g., SOPs, Specifications, Methods, etc.) to ensure strict compliance of R&D functional operation with ISO 13485/ 21 CFR 820 Quality System/ EN requirements.
• Supports continuous improvement of the Quality Systems.
• Applies Statistical tools to support product development process.
• Provides QS knowledge to organization as needed.  Administers appropriate training as needed.
• Participates in the ongoing operations of QA/QS activities.

Requirements:

• Educational Background: Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering discipline.
• Professional Experience: 1-5 years of relevant experience
• Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).
• Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry.
• Demonstrated hands-on experience with Design Control procedures.
• Experience in a Phase-Gate development process.
• Experience in directly applying statistical methods for quality improvement.
• Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.
• Good technical writing skills.
• Familiarity with statistical methods and analysis and/or Minitab software. 
• Team player with excellent interpersonal and communication skills.