Senior Software Quality Assurance Engineer
Full-timeSenior
Description
Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>What you will do:</b></p><ul><li><p>Primarily responsible for Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, Test log test plans, Software verification and Validation, Product Security documents review.</p></li><li><p>Owns Risk Management per ISO14971 to ensure the safety and effectiveness of product.</p></li><li><p>Responsible to ensure provisions of software life cycle processes are followed and associated reviews are conducted.</p></li><li><p>DQA shall drive coordination with different departments (such a R&D, Testing, Regulatory, Post Market Quality) to ensure the resulting part/product/process is safe, compliant and effective</p></li><li><p>Conduct design reviews during various phases of NPD.</p></li><li><p>Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.</p></li><li><p>Work with team to develop robust software architecture as per quality and regulatory requirements.</p></li><li><p>Expert-level knowledge of current industry standards for software engineering and risk management practices ideally from the domain of safety critical applications</p></li><li><p>Demonstrated ability to apply software and system quality management practices in efficient and effective ways while being compliant.</p></li><li><p>Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).</p></li><li><p>Good interpersonal and communication skills.</p></li></ul><p></p><p><b>What you need:</b></p><p></p><p><b>Required Skills:</b></p><ul><li><p><span>5+ Years’ experience in new product development focused on quality engineering related activities. Strong preference given to medical device industry experience). Education: B.Tech/BE in Computer Science or Electronics Engineering</span></p></li><li><p><span>Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304</span></p></li><li><p><span>Experience on NPD process and various phases of new product development.</span></p></li><li><p><span>Knowledge of ISO 14971, IEC 62304, 60601-1 family of standards.</span></p></li><li><p><span>Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001)</span></p></li></ul><p></p><p><b>Preferred Skills:</b></p><ul><li><p><span>Familiarity with basic programming language, embedded software & tools.</span> <span>Ability to review Defects.</span></p></li><li><p><span>Ensure that software, mechanical, electronic, and material/implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.</span></p></li><li><p><span>Provide expertise in establishing good specifications and protocols like requirements, architecture, detailed design, verification & validation planning, etc.</span> <span>Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.</span></p></li><li><p><span>Conduct and moderate all kind of Design Reviews (e.g. SRS Reviews, source code reviews, etc.).</span> <span>Establish overall system test design in cooperation with test engineering.</span> <span>Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.</span></p></li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 20%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>