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Quality Engineering Manager - Manufacturing

Company: Medtronic
Location: hialeah
Posted on: May 3, 2021

Job Description:

Careers That Change Lives In this exciting role as a Quality Engineering Manager you will have responsibility for managing the quality engineering production support team for MCS in Miami Lakes.Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.Position will be responsible for managing the team in support of product realization activities for MCS manufacturing and logistics processes. Will lead a group of individuals responsible for providing engineering/technical support for pilot and standard production in a GMP setting for an active implantable class III medical device facility. This individual will be responsible for application of engineering concepts and techniques to a variety of assembly processes. Will oversee QA responsibilities including DMR documentation review, pFMEA/control plan creation/execution, process validation support, participation in risk management activities, administration of non-conformance management process and supervision of quality engineer and technicians. In addition, will ensure that all sustaining and manufacturing activities are carried out in a manner consistent with regulatory requirements.Will manage employee development, including providing timely feedback, periodic performance reviews, and ensure that employees are provided training on technical topics, regulatory requirements and leadership and personal development.Mechanical Circulatory SupportThe 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. The HVAD System features the world's smallest, commercially available, centrifugal flow pump.A Day in the Life Responsibilities may include the following and other duties may be assigned. Collaborates with other functional teams (e.g. manufacturing engineering, supplier quality, logistics) to resolve production issues in a compliant and effective manner. Mentors and develops quality engineers in support of manufacturing activities. Ensures non-conforming process is executed consistently in a timely manner including containment, disposition and escalation actions. Supports and participates in FDA, BSI and other internal external audits May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. Monitors documentation maintenance throughout manufacturing. Selects, develops and evaluates personnel to ensure the efficient operation of the function.Must Have: Minimum RequirementsBachelor's Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering, Quality, and/or experience in a regulated industryNice to Have Experience with FDA inspections Process Excellence certifications such as FTQ, 6 Sigma Belt, DRM Prior people leadership experience Experience in an Operations Quailty environmentAbout 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)Less than 10% travel domestic and international

Keywords: Medtronic, Hialeah , Quality Engineering Manager - Manufacturing, Other , hialeah, Florida

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