Director of Quality

We are seeking a dynamic Director of Quality to lead Israel's quality Department and be a strong business partner. This position will play a pivotal role in the company's success in treating OSA worldwide.

 In collaboration with the Chief Quality & Regulatory Officer, this is both a hands-on and leadership opportunity for a Director of Quality to join and further improve the IS quality activities including design, quality engineering, compliance, QMS, manufacturing quality,  supplier quality, and others.

 The director of Quality Israel will work closely with peers and stakeholders to achieve key quality objectives while managing Israel's activities and supporting its global vision. This position will ensure quality and regulatory/compliance requirements are met. This role will contribute to overall quality strategy development, working closely with all functions and business leaders, and executing on day-to-day quality activities.

Responsibilities:

●     Provide quality solutions to its function as well as to the business and ensure all quality requirements are met

while ensuring business needs are also met.

●     Develop organizational goals and objectives as well as KPIs in line with the overall Quality strategy.

●     Provide leadership and direction to Quality teams and employees including conducting performance reviews,

talent management, and managing its budget.

●     Develop, maintain, comply, and proactively manage QMS to ensure compliance with all global requirements and

standards including, but not limited to, US FDA QSR/CFR Part 820, ISO 14971, ISO 13485, and MDD/MDR,

MDSAP, Canada, Brazil, EU, and other country requirements.

●     Hold regular quality management reviews with business and functional leaders to provide an update on overall

quality performance.

●     Establishing and leading the quality organization, covering various functional areas such as design, quality

engineering, compliance, QMS, manufacturing quality, and supplier quality.

●     Ensure product quality and process are robust, efficient, and effective as well as it meet the needs of the

business while ensuring compliance to regulatory requirements.

●     Conduct and manage both internal and external audits – as well as identify areas of improvement.

Qualifications:

●     Bachelor’s degree in engineering, quality assurance, or related discipline; Master’s degree a plus.

●     Minimum of 3 years of progressive quality experience as a Director in medical devices.

 5+ years' experience in a senior managerial role.

●     Strong knowledge of regulations and standards as well as know how to implement them effectively. This

includes in-depth knowledge of quality and regulatory requirements and standards.

●     Strong understanding of post-market surveillance, QMS, CAPA, and risk management

●     Strong communication skills and able to demonstrate prudent decision making skills, while able to move with

sense of urgency and speed

●     Ability to convey complex quality and regulatory concepts clearly and understandably

●     Able to conduct audits as well as manage audits and inspections

●     Familiar with medical device industry and its practices, including emerging trends and best practices

●     Experience supporting regulatory submissions to FDA for medical devices (Class III preferred). Strong

background in FDA inspection processes and PMA (premarket approval) experience is a plus. 

●     Demonstrated success in building and leading high-performing quality teams.

●     Excellent communication and interpersonal skills.

●     Results-oriented with a focus on achieving regulatory milestones.

●     Strategic thinker with the ability to contribute to organizational growth.