Careers that Change LivesA career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.A Day in the LifeIn this exciting role as a Quality Systems Specialist, you will have responsibilityfor managing Quality Systemsat Medtronic in Parker, CO.Parkeris part of theCardiac Surgery Operating Unit. The individual in the role will have the ability to work with multiple Medtronic teams across the United States.Cardiac Surgeryrepresentsendstage treatment in the care continuum for many cardiovascular diseases, and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio.Responsibilities may include the following and other duties may be assigned.·Provides oversight for developing andmaintainingquality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform toestablishedinternal and external standards and guidelines.·Providesexpertiseand guidance in interpreting policies, regulatory and governmental and internal regulations to assure compliance.·Works directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet regulations.·Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.·Ensures the quality assurance programs and policies aremaintainedand modified regularly.·Is responsible forthe control of documents. oLiaises with operations supervisors, leads, and Incoming Inspection to ensure the proper revisions of procedures are available. oControls andmaintainsthe old revisions according to policies and regulations.·Functions as the Calibration Coordinator for the site. oCoordinates with Calibration Vendors and site Engineering to ensure tools and equipment are calibrated on time. oMaintains calibration certificates and the calibrations database. oIs responsible forrepresentingcalibration during internal and external audits. ·Functions as the NCMR (Non-Conforming Material) Coordinator. oLeads weekly MRB (Material Review Board) meetings and ensures theappropriate functionsattend. oEnsures the NCMRprogressto closure and that quality metrics around NCMR timeliness are met. oReport out to upper leadership on NCMR metrics. Maintains minutes of the weekly PRB meetings·Performs Configuration Assurance work for thesiteoFunctions as the Change Analyst for all documentation changes.oEnsures the changes are created correctly and according to procedures and regulations.oEnsurestimelyprocessing of the changes.oWillbe responsible forassistingEngineering, Manufacturing, and Quality with change order creation.Must Have: Minimum RequirementsBachelors degree requiredMinimum of 2 years of relevant experience, or advanced degree with 0 years of experienceNice to HaveBachelor's degree preferably in Engineering, Quality or equivalentMinimum of 2+ years of relevant experience (Quality System Specialist role or must be knowledgeable with QMS Processes (Document Control,Non-ConformingProduct,Corrective and Preventive Action,Audit,Calibration,Manage Compliance), or advanced degree (Master) with 1+ years of experience.Non-Conformance experienceConfigurationAssurance experienceQuality Management System experienceQuality System Regulation experienceGood communicationskills, fluent in communication in English.Excellent knowledge of MS Office, Excel, and computer systems.Previousexperience leading programs and projects for quality functional groups.Quality management or document control experience.Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance processes orprograms Team player.Knowledge of FDA and Regulations.Technical Writing experience.About MedtronicTogether, 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 RequirementsThe 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)A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP)here.The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
