Job TitleQMS Manager
In this role, you have the opportunity to
join a fast-growing Philips 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 QMS responsible within the team, with a primary focus on the R&D team.
You are responsible to
- Managing the full implementation of the quality management system 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
Philips EPD Solutions, 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 Management System experience in a Medical Device industry
- Extensive knowledge about quality systems, and a thorough understanding of quality principles and practices
- Knowledgeable about medical regulations and international regulatory requirements
- Experience in implementing ISO standards
- Extensive experience as an internal auditor for notified bodies
- Experience with healthcare software engineering is a strong advantage
- Experience with supervising 1 or more professionals
- is a preference
- 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.
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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