Design and Software Quality Assurance Manager
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 Manager to join our QA group and to support our meaningful growth.
What will you do?
- 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 with internal procedures and quality regulations
- Develop and Implement process and SW/HW Validation and verification policy and procedures
- Identify the opportunities for continuous improvement of the Quality System
- Provide guidance and decisions on R&D activities to ensure compliance with internal procedure and regulatory requirements
- Write validation protocols and reports
- Defect Tracking and Management
- Identify opportunities to proactively assure compliance to international quality regulations e.g., ISO 62304 ISO 13485, ISO14971, US 21 CFR 820 etc.
- 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.
- Ability to partner with R&D departments and collaborate with various departments within the organization
- Experience in implementing and guide quality standards in day-to-day activity
- Impactful experience in product and process validation, software validation (device & quality system support), test method validation, statistics, risk management tools
- Significant experience in Software development lifecycle
- 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