MDR / Vigilance Specialist
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IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME:
REQUIRED EDUCATION:
• Bachelor’s Degree
REQUIRED YEARS OF EXPERIENCE:
• 2+ years (with Bachelor's) or less than 1 year (with Master's) of experience in a health, clinical, technical, or scientific field
SPECIALIZED KNOWLEDGE REQUIRED:
• Experience in a clinical or regulated environment
DESIRED/PREFERRED QUALIFICATIONS AND SPECIALIZED KNOWLEDGE:
• Experience working as a health care professional
• Backgound in Heart Failure and/or with Left Ventricular Assist Devices
• Knowledge of CRHF products and therapies
• Lean Sigma Experience (Green Belt/Black Belt)
• Experience with complaint handling, MDR/Vigilance reporting
• Knowledge of 21 CFR Part 820, Quality System Regulations
• Knowledge of 21 CFR Part 803, Medical Device Reporting
• Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA
• Attention to detail
• Strong communication skills
• Can work independently in a team environment
• Takes initiative and proactively seeks quality solutions through continuous improvement
• Proficient in word processing, spreadsheet, database and presentation applications
• Effective priority setting
• Experience working with customers
PHYSICAL JOB 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 for extended periods of time, and communicate with peers and co-workers which may require travel to and from multiple work locations.
• The employee is also required to read small font on a computer screen/monitor for 6-8 hours/day.
• The employee is also Required to type & perform analysis for 6-8 hours/day.
ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
