Senior Software Quality Assurance Engineer

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 wont 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: 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 -1 family of standards.

• Understanding of Quality Management Systems. (ISOCRF 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.