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Job Opportunity: Software Quality Assurance Manager

Date   Oct 25
Listing No.   IE260934
Sector   Quality Control & Assurance
Region   North
City/Yishuv   Caesaria
Software Quality Assurance Manager
In this role, you have the opportunity to

Join a fast-growing venture, disrupt a billion dollar industry and touch millions of lives by developing a unique medical device solution.

You will have the opportunity to work with a very entrepreneurial venture organization and support the growth of this organization with the right fundaments and will be the quality responsible within the team, with a primary focus on the software design controls and quality assurance.

You are responsible to

Assure and control the software design quality of EPD products
Work closely with the Validation & Verification team and review their output (test reports and results and raw data)
Managing the full implementation of the quality management system in the R&D team and ensure that the company is in compliance with standards and regulations (e.g., QSR, CMDR and MDD)
Implementing most aspects of the quality system including document and data control, management responsibility (including management review), quality planning, training, vendor approval / monitoring, process validations, corrective and preventive action system, internal quality audits
Promoting awareness of regulatory and customer requirements
Participating as applicable in design control and risk management as quality assurance manager

You are a part of

A recently acquired venture with ambitious plans for growth, developing a disruptive technology, which will improve the efficiency and efficacy of life-saving cardiac ablation procedures treating among others atrial fibrillation. EPD’s technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. We aim to help to improve outcomes for millions of people and help maintain the rapidly rising cost of managing the disease. Having obtained CE mark in 2018, we are preparing for a commercial product launch in Europe, US and other territories and are seeking regulatory approvals around the world.

You will have many interfaces with the corporate Q&R team in Best Eindhoven and will be based in Caesarea, Israel. You will be reporting into the global Q&R Manager of EPD in the US.

To succeed in this role, you should have the following skills and experience

A Masters or Bachelor Degree in Engineering, Life Sciences, Quality or Business Management, preferably with experience working in a highly regulated business.
Minimum of 7 years of Quality Assurance and Design Control experience in a software based products in Medical Device industry
Extensive knowledge about quality systems, and a thorough understanding of quality principles and practices, as well as the software hazard evaluation process (risk management)
Knowledgeable about medical regulations and international regulatory requirements
Thorough understanding of ISO standards
Understanding Python and or C++ coding language is a big advantage
Extensive experience as an internal auditor for notified bodies
Excellent verbal and written communication skills in English
Excellent organizational skills and ability to execute on multiple priorities in a fast paced environment

We will only consider local candidates for this position.
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