What you will do:
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.
Owns Risk Management per ISO14971 to ensure the safety and effectiveness of product.
Responsible to ensure provisions of software life cycle processes are followed and associated reviews are conducted.
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
Conduct design reviews during various phases of NPD.
Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
Work with team to develop robust software architecture as per quality and regulatory requirements.
Expert-level knowledge of current industry standards for software engineering and risk management practices ideally from the domain of safety critical applications
Demonstrated ability to apply software and system quality management practices in efficient and effective ways while being compliant.
Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
Good interpersonal and communication skills.
What you need:
Required Skills:
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
Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304
Experience on NPD process and various phases of new product development.
Knowledge of ISO 14971, IEC 62304, 60601-1 family of standards.
Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001)
Preferred Skills:
Familiarity with basic programming language, embedded software & tools. Ability to review Defects.
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.
Provide expertise in establishing good specifications and protocols like requirements, architecture, detailed design, verification & validation planning, etc. Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
Conduct and moderate all kind of Design Reviews (e.g. SRS Reviews, source code reviews, etc.). Establish overall system test design in cooperation with test engineering. Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.
