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Senior Quality Systems Specialist

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Quality
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210008XK Requisition #

Careers that Change Lives

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you. Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives.

A Day in the Life

   As a part of your job you will:
•  Lead activities and maintenance of quality programs, systems, processes and procedures to ensure   
   compliance with to established internal and external standards and guidelines. 

•  Works directly with organization functions in Mazor to provide process analysis oversight on a
   continuing basis to enforce requirements and meet regulations.

•  Host auditing groups and inspectors during inspections

•  Participate in audit and inspection preparation, resolution of audit and inspection findings 

•  Perform internal quality audit

•  Prepares reports and/or necessary documentation and provides to applicable stakeholders, both
    internal and external.

 

Must Have:

  •   B.S. Degree and minimum of 4+ Years of Quality Assurance experience in Medical device companies

            or other highly regulated industries

  •   Understanding and knowledge of applicable regulations and standards (Such as FDA  21 CFR QSR

             820, ISO 13485, ISO 14971, EUMDR, MDSAP, Etc)

  • Fluent in written English and Hebrew

Nice to have:

  • Previous experience in executing Corrective and Preventive action, NC, training and document control .
  • Experience with Cornerstone, Trackwise, Agile

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 

PHYSICAL REQUIREMENTS

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe it’s the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us, and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer —your unique perspectives, talents and contributions —we can live up to the promise of our Mission

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FORTUNE NAMES MEDTRONIC TO 'CHANGE THE WORLD' LIST

FORTUNE puts Medtronic among the top 20 companies worldwide having a positive social impact through core business strategy.

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ENGINEERING

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INCLUSION AND DIVERSITY

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

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