Design Quality Assurance Director

Tel Aviv

Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe and Israel, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease. As an increasingly growing company we’ve been accepted to FDA’s prestige Breakthrough Device Designation program.

We are looking for an experienced Design and Software Quality Assurance Director to join our QA group and to support our meaningful growth.

What will you do?

• Lead Design Assurance team and Provide Design Assurance/Quality Engineering leadership in direct support of R&D teams
• Provide guidance for SW/HW product development under Design Controls and Software Development Lifecycle processes
• Assist with defining and documenting product requirements in accordance to internal procedures and quality standards and regulations
• Develop,Implement and maintain Design Control process and SW/HW/System Validation and verification policy and procedures
• Identify the opportunities for continuous improvement of the Product and minimizing risks associated with use of the product through design
• Provide guidance and decisions on R&D activities to ensure compliance with internal procedure and regulatory requirements
• Partnering with R&D for proper documentation of Deign activities
• Take leadership role in Defect Tracking Management
• Define and implement process control & monitoring over R&D projects and development processes

What do you need to bring with you?

• Bachelor’s degree in Electrical/SW Engineering
• 5+ years of experience in Design Assurance at Medical Device companies (active implants companies – an advantage)
• Familiarity with international quality regulations – ISO 62304, ISO 13485, ISO 14971, US 21 CFR 820 etc.
• Experience in implementing and guide quality standards in day-to-day activity
• Experience in product and process validation, software validation (device & quality system support), test method validation, statistics, risk management tools
• Experience in writing design validation and verification protocols
• Experience in defect tracking and management
• Technical writing skills
• An ability to successfully communicate and educate QMS regulations, policies and strategies to employees at all levels of the organization