Staff Quality Engineer

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.

Travel Percentage: 50%