• 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%