Careers that Change Lives

　　SR. QUALITY ENGINEER - IRVINE, CA | NEUROVASCULAR

　　A 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. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. See our videos below to learn more about our diverse workforce why Medtronic is an employer of choice.

　　Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

　　In this exciting role as a Senior Quality Engineer, you will be responsible for implementing, maintaining, and improving the Quality Management System at the Irvine site. Specifically review and revise, as needed, QMS policies and procedures to ensure the work conducted conforms to established corporate and group processes and industry regulations/standards. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. This role will also participate in external Audits, and/or internal audits.

　　As part of Medtronic's Neuroscience Portfolio, Medtronic Neurovascular develops and markets medical technology, services and solutions to treat patients afflicted with Acute Ischemic and Hemorrhagic Stroke worldwide.

　　To drive the synergies across the 4 sites that exist in Orange County under Vascular Therapies Implants and Drug and Chemistry Technologies, we are introducing the OC Campus Strategy, which will include the harmonization of all Orange County manufacturing campuses including:

　　• Santa Ana – Surgical Valve and Transcatheter Valve

　　• Anaheim (Vascular Medcure) – Capere Thrombectomy and Embolectomy system

　　• Irvine – Stroke/Aneurysm and Embolization

　　• San Juan Capistrano (Avenu) – Ellipsis Vascular Access System and Power Controller

　　The vision of the OC Campus is to accomplish harmonized standards and process amongst the sites.

　　Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business. Medtronic seeks candidates who will meet our customer expectations by striving without reserve for the highest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.

　　We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

　　We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. To learn more, we invite you to visit Medtronic Benefits (https://benefits.medtronic.com/)

　　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.

　　To learn more about Inclusion & Diversity at Medtronic Click Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)

　　A Day in the Life

　　Responsibilities may include the following and other duties may be assigned.

　　Quality System Management: Create and revise standard operating procedures, as needed. Perform ongoing gap analysis against Group and Enterprise requirements and regulations to include routing and release of documentation in MAP Agile and working with managers to assign employee training. Ensure local team is following procedures and the QMS is operating effectively. Update and/or manage Quality Metrics. Assist with Management Review and Corrective Action Board meeting preparations. Function as the site key compliance contact.

　　Audit: Assist in preparations for internal and external audits. Lead or participate in audits, as needed. Support external regulatory audits as needed. Support DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.

　　Corrective and Preventive Action (CAPA) Management : Evaluate, trend and triage issues that may be considered CAPAs. Communicate effectively and ask the right questions of team members while presenting issues, trends and feedback clearly at CAPA Board Meetings. Actively track CAPA’s, as needed, and remain diligent to ensure the tasks are completed on time. As needed, assist team in developing solutions to problems via effective means of root cause analysis, and offer possible improvements to processes and systems.

　　Data Analytics (KPI): Leverage analytical tools to deliver solutions that help solve business problems (Power BI, Power Apps, SharePoint Online, Excel, etc.). Deliver ongoing reporting & analytics of KPIs at the Sr Leadership/site performance meetings.

　　Must Have: Minimum Requirements

　　To be considered for this role, please ensure the minimum requirements are evident on your resume.

　　Bachelors’ degree in Engineering, Science or Technical field.

　　Minimum of 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.

　　Nice to Have

　　Experience working with CAPA, Management Review, Change Control and Audit processes.

　　Experience with TrackWise and Agile PLM software

　　Working knowledge of 21CFR 820, ANVISA, ISO 13485, MDSAP, etc.

　　Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.

　　Experience reviewing technical documentation.

　　Strong written and verbal communication skills

　　Strong critical thinking and analytical skills

　　Previous experience leading programs and projects for quality functional groups

　　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)

　　A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .

　　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 (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

　　Min Salary

　　90000

　　Max Salary

　　135000

　　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.