Job Description

Summary We are seeking an experienced Supplier Quality Engineer to ensure suppliers consistently deliver high-quality parts, materials, and services that meet company, regulatory, and customer requirements. This position will partner with cross-functional teams, including R&D, Sourcing, Engineering, Operations, and Quality, to support supplier qualification, supplier changes, product quality, defect prevention, and continuous improvement throughout the product lifecycle. Responsibilities Ensure suppliers deliver quality parts, materials, and services in accordance with established company standards. Qualify and evaluate suppliers according to company requirements and applicable quality standards. Support and/or administer Certified Supplier Programs and receiving inspection activities to improve quality and cost effectiveness. Monitor purchased parts and components from acquisition through the manufacturing cycle. Identify, communicate, investigate, and support the resolution of supplier-related quality issues. Evaluate supplier operations and internal quality systems to assess overall performance and provide appropriate feedback. Partner with cross-functional teams, including R&D, Sourcing, Engineering, Operations, and Quality, to prevent defects and ensure the delivery of reliable, high-quality products. Provide technical guidance and quality compliance support throughout the product lifecycle, with particular focus on supplier-related changes. Implement strategies to improve supplier and product quality while supporting continuous improvement initiatives. Ensure purchased products and components are manufactured and qualified according to applicable industry standards, regulatory requirements, and customer requirements. Collaborate with cross-functional teams to develop and implement Product Acceptance Sampling Strategies, Approved Supplier List coordination, Supplier Owned Quality initiatives, and Control Plans for new products. Define Receiving Inspection requirements as needed. Support test method validation activities for applicable internal test methods. Perform other duties as assigned. Requirements Bachelor’s degree in Engineering, Science, Quality, or a related technical discipline. Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience. Demonstrated experience with Medical Device Industry or Automotive part qualification requirements. Advanced knowledge of supplier quality, quality systems, manufacturing processes, and component qualification. Knowledge of applicable regulatory and industry quality requirements. Strong analytical, problem-solving, communication, and cross-functional collaboration skills. Practical knowledge of project management is preferred. Technical Skills Knowledge of ISO 13485 requirements. Knowledge of FDA Quality Management System Regulation (QMSR) requirements. Knowledge of Geometric Dimensioning and Tolerancing (GD&T). Experience with supplier and/or component qualification activities. Experience with receiving inspection requirements and test method validation. Experience using Agile is a plus. Experience using TrackWise is a plus. Willing to work 100% on site in Juncos, PR.