Work Flexibility: Hybrid
What you will do:
• Primarily responsible for: Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER.
• Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
• Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.
• Participate in design reviews during various phases of NPD.
• Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
• Expert-level knowledge of current industry standards for New Product Development and risk management practices.
• Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
• Exposure to any Programming language & on Software Testing concepts.
• Design And User Validation exposure.
• Good interpersonal and communication skills.
What you will need
Education: B.Tech/BE in Computer/ IT/ Electronics Engineering
• Experience: 5- 9 years
Personality:
o Demonstrated organizational and written/verbal communication skills.
o Demonstrated ability to self-motivate
o Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
o Demonstrated ability to prioritize tasks in a deadline-driven environment.
Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
• AQE should drive coordination with different departments (such a R&D, Test, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant and effective.
• Experience on NPD process and various phases of new product development.
• Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
• Design and User Validation.
• Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
• Knowledge of IEC 62304 standard for Medical device software.
• Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
• Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.