In this role, you have the opportunity to
be accountable for oversight of document control and quality throughout the software lifecycle. The Design and document control Specialist for Software independently audits the adequacy of design specifications, V&V test plans, and reliability test plans for software validation from GDP perspective.
Position is located at Raanana
You are responsible for
Ensuring that appropriate SW Quality plans are made that include all stages of the software life cycle
Reviewing all design control artifacts and maintains Design History file for various software releases
Ensuring that Design History file is ready and approved prior to milestone approval
SME on Document control and Good documentation practice matters
Providing effective oversight of the execution of the SW Quality Plan and any Risk Management activities, all design related activities during the software lifecycle
Leading quality related problem solving for software
Acting as a single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every PRP milestone
You are a part of
EDI (Enterprise Diagnostic Informatics) Q&R Organization. Our mission to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. We enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs. Our research and business provides unique opportunities to develop cutting-edge clinical solutions and deliver meaningful solutions in the healthcare space.
To succeed in this role, you should have the following skills and experience
Relevant academic degree
Minimum of 5 years of similar work experience, in Medical Devices companies. Software Medical Devices companies – an advantage
Good understanding of the Quality System Regulation (ISO 9001 ISO 13485, 21 CFR Parts 803, 806 and 820)
Experience with business-related implementation projects, including being an active leader\contributor on projects with scheduled deliverables
Ability to interact and communicate in English, including demonstrable writing, speaking and comprehension skills; ability to communicate across levels of the organization
In return, we offer you
Endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already.
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 at https://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video at https://youtu.be/ocnMFp1JBuM .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at https://www.careers.philips.com/professional/global/en/workingatphilips on our career website, where you can read stories from our employee blog at https://www.careers.philips.com/global/en/blog-unexpected . Once there, you can also learn about our recruitment process at https://www.careers.philips.com/global/en/recruitmentprocess , or find answers to some of the frequently asked questions at https://www.careers.philips.com/global/en/faq .