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. Your unique talents will help shape the future of healthcare while building a career grounded wth, and impact.A Day in the LifeAt Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts.This role is remote or Lafayette, CO.As a Supplier Quality Engineer II, you will play an important role on cross-functional core teams supporting all Medtronic's sites and regions. This position is responsible for negotiating, reviewing, and approving Quality Agreements with suppliers to ensure alignment on quality system requirements, regulatory compliance, and operational responsibilities.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 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 ulatory 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 Baccalaureate degree and minimum of 2 years of relevant quality experience OR Master's degree with a minimum of 0 years relevant experience.Nice to Have (Preferred Skills):Prior knowledge with ISO13485 standardsExperience negotiating and finalizing Quality Agreements with external suppliersStrong knowledge of supplier quality requirements and applicable regulationsAbility to interpret quality system requirements and translate them into contractual obligationsExcellent written and verbal communication skillsProven cross-functional collaboration with sourcing, legal, regulatory, and operations teamsStrong risk assessment, issue resolution, and decision-making capabilitiesHigh attention to detail lining, and approval workflowsFor 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 RequirementsThe 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 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
10 days ago