Supplier Qual Engineer II

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As a Supplier Quality II, resource will be responsible to support Sustaining activities to Manufacturing Operations evaluating non-conforming components of External Suppliers.                     Responsibilities may include the following and other duties may be assigned. • Ensures that suppliers deliver quality parts, materials, and services. • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. • Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: 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. • Collaborates with Component 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. Required Knowledge and Experience: Requires a Bachelor degree in engineering and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience. Nice to Have: • Experience qualifying suppliers, manufacturing processes, materials, or components. • Experience applying quality tools such as root cause analysis, Corrective and Preventive Action (CAPA), risk management, or statistical analysis. • Knowledge of supplier quality systems, auditing practices, and quality control methodologies. • Experience working within regulated industries and quality management systems. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are represent