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.
•    Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
•    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.
 

What you will need:

Required Qualifications:

• Bachelor’s or master’s degree in software engineering/ computer science or related discipline.

• Minimum 6 years of relevant work experience.

• Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)

• Experience on NPD process and various phases of new product development.

• Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.

• Knowledge of IEC 62304 standard for Medical device software.

Preferred Qualifications:

•  Design and User Validation.

•  Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.

Travel Percentage: 50%