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%