Sr Supplier Quality Engineer – Pre-Market Req Number 21000WLR Location – Rice Creek, MN or Northridge, CA Careers That Change Lives In this exciting role as a Sr. Supplier Quality Engineer – Pre-Market Quality you will have own the responsibility to p rovide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD projects. You will work in partnership with the Technical Sourcing , R&D and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements. Diabetes The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease. A Day in the Life Responsibilities may include the following and other duties may be assigned. Understand and operate to medical device regulatory guidelines (GMP, FDA, ISO13485) and company Quality System procedures. Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products. Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements. Perform statistical analysis using Minitab to ensure supplier has acceptable capability in process validations. Perform GR&R, TMVs and review / approve IQ/OQ/PQ data from supplier component qualifications. Quality governance of selection of new suppliers to the Approved Supplier List (ASL) Develops and prioritizes an NPI auditing schedule to ensure that new suppliers are audited initially as part of their qualification process. Prepare and negotiate Quality Agreements with suppliers Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Collaborates with R&D Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products. Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods. 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 with 4+ years of experience in Engineering and/or Quality OR Advanced degree in engineering, science or technical field with 2+ years of experience in Engineering and/or Quality. Nice to Have Prior experience in regulated medical devices is desirable. DMAIC certification/ Knowledge and experience in areas of Lean Manufacturing and Six Sigma ASQ certification in Quality Engineering Design for Reliability and Manufacturing knowledge Able to perform statistical analysis in Minitab Supplier Qualification process knowledge and experience Strong interpersonal, organizational and project management skills Able to use critical thinking skills. Demonstrated communication skills, both verbal and written, Strong interpersonal communication and influence skill 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: 25% locally and internationally as applicable Additional Information - Posting Date: Dec 15, 2021 - Travel: Yes, < 25 % of the Time
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