Quality Engineer

Job Description Summary P3-11554 Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts. Job Description P3-11554 Educational Background: Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering discipline. Professional Experience: 0-5 years of relevant experience Job Responsibilities  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. Knowledge and Skills a. Knowledge  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. b. Skills  Good technical writing skills.  Familiarity with statistical methods and analysis and/or Minitab software.  Team player with excellent interpersonal and communication skills. Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)  Familiarity with Six Sigma methodology.  Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies.  Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods). Strong critical thinking, analytical, and problem-solving skills. Any additional Information (Specially if needed for Quality or legal purposes) • Certified Quality Engineer (CQE) • Certified Six Sigma Green Belt (SSGB) and/ or Six Sigma Black Belt (SSBB) Required Skills Optional Skills . Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.