Supplier Quality Engineer-

Requirements

• Experience in medical device, pharmaceuticals, or other regulated manufacturing environments.
• Knowledge and application of PPAP processes, including supplier change management and validation activities.
• Experience managing NCMRs , root cause investigations, and CAPA activities.
• Experience supporting internal, supplier, customer, and regulatory audits.
• Supplier quality management experience, including qualification, performance monitoring, and continuous improvement.
• Familiarity with risk management tools such as FMEA and risk assessments.
• Working knowledge of GMP , ISO 13485 , FDA regulations, and applicable quality standards.
• Experience supporting supplier quality activities within New Product Development (NPD) projects.
• Knowledge of receiving inspection, sampling plans, control plans, and test method validation.
• Strong collaboration skills with cross-functional teams, including Engineering, Manufacturing, and Quality.
• Experience using quality management and ERP systems such as SAP, TrackWise, Agile, or MasterControl.
• ASQ certifications (CQE, CQA) or equivalent quality certifications are a plus.
• 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.
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Benefits

Additional Information

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Supplier Quality Engineer responsible for ensuring suppliers consistently deliver compliant, high-quality materials, components, and services that support medical device manufacturing operations. Leads supplier qualification, auditing, performance evaluation, issue resolution, and continuous improvement initiatives to ensure adherence to GMP, regulatory requirements, and internal quality standards. Collaborates closely with New Product Development, Component Engineering, Manufacturing, and Quality teams to support supplier quality activities throughout the product lifecycle, including supplier selection, component qualification, control plan development, receiving inspection strategies, and test method validation. Supports supplier-initiated changes through the assessment, validation, and approval of modifications utilizing the PPAP process. Drives risk mitigation, defect prevention, and supplier performance enhancement efforts to ensure the consistent delivery of safe, reliable, and high-quality medical devices. 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. Must Have: Minimum Requirements: Requires a Bachelor degree in Engineering minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience. Bilingual (Spanish & English)

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