Sr. Quality Systems Program Manager - Remote , Miami Lakes or Mounds View, MN
Job description
-Mechanical Circulatory Support
The Mechanical Circulatory Support Operating Unit is responsible for Medtronic’s heart pump program. Called the HeartWare™ HVAD™ System, this business provides a left ventricular assist device (LVAD) that helps patients’ hearts pump and increases the amount of blood that circulates through their bodies.
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Leads planning and execution of the PSQIP for the MCS OU. Includes cross-functional planning, execution facilitation, and status reporting to OU and Enterprise leadership.
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Leading CAPA process improvement and standardization. Developing standard work processes for the efficient and complian execution of CAPAs are efficient and compliant. Ensuring CAPA records are audit ready.
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Supporting process improvement in the QMS supporting processes.
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Supporting external and internal audits in the front room and back room as needed.
Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering, Quality, and/or experience in a regulated industry with 5+ years of leadership experience
OR Advanced Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry with 5+ years of leadership experience
Nice to Have:
External audit experience, both front room and back room. FDA audit experience preferred.
CAPA experience
Experience responding to audit observations and resolution of Warning Letter or other regulatory enforcement actions.
Experience in manufacturing a Class III active implantable medical device.
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 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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Travel
< 15% travel.
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