Verification and Validation Team Leader

3 weeks ago

Toronto, Canada Conavi Medical Full time

Imagine your future at Conavi

Join our collaborative team in the design, manufacture, and sale of an innovative intravascular imaging system to improve cardiac care.

Conavi Medical’s Novasight Hybrid System enables simultaneous imaging of a patient’s coronary arteries using both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT) technologies.

If you would like to be a part of a growing and talented team that is making a difference in healthcare, we are currently looking for a Verification and Validation Team Leader to lead the planning and executing of software and engineering system verification & validation, training, monitoring, and re-validation in compliance with ISO 13485 and MDSAP quality standard and regulatory agency requirements.

In this position, you will:

- Consult on software and hardware user requirements, functional and design specifications from a quality perspective
- Determine the testing scope, documentation and verification activities aligned with schedules and a risk-based approach
- Generate verification and validation plans, qualification protocols, and test plans, and trace matrixes
- Lead as well as individually perform software and systems verification and validation process activities including generating test scripts, executing testing, and preparing documentation such as reports
- Communicate timely status, solutions, and concerns with R&D leadership as well as with other key stakeholders
- Support reviews and improvements of the product verification and validation process in alignment with the Quality Management System (QMS) and applicable quality regulations
- Manage Verification and Validation Specialists including recruitment, employee relations, as well as learning and development
- Promote, and participate in health & safety initiatives and compliance

You possess the following qualifications:

- Post-secondary education in software, engineering, or science
- Highly skilled in software and system testing and validation in the medical device industry
- Proficient in the various testing phases such as Manual Testing, GUI Testing, Functionality Testing, Security Testing, System Testing, Regression Testing, Integration Testing, Performance/Stress Testing, User Acceptance Testing
- Experience with use/control of Electronic Records/Electronic Signatures and electronic submissions to regulatory agencies
- Knowledge of process measurement and analysis methodologies
- Knowledge of software testing, mechanical testing, and electrical testing methodologies
- Experience with Design of Experiment (DOE)
- Working knowledge and understanding of ISO 13485, ISO 14971, CFR Title 21 Part 11
- Computer knowledge including proficiency with Microsoft Office (Word, Excel, Outlook, Project)
- Knowledge of statistical analysis protocols
- Ability to successfully influence without authority inter and intra department
- Professional, and clear written and verbal communication skills

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