Senior Supplier Quality Engineer

Job Description SummaryThe primary purpose of this position is to develop the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMPISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance.Essential Duties & Responsibilities:Improve supplier quality performance for assigned suppliers.Manage supplier audit program and overall supplier approvalrating program through robust qualification processes.Assure supplier compliance to Lake Region Medical QMS and regulatory requirements through supplier monitoring process.Manage the supplier process change process.Develop positive relationships and work closely with Engineering and Supply Chain to manage and implement supplierengineering changes, New Product Introductions, and terface with Suppliers, Engineering, Operations and Supply Chain to drive Quality improvements that minimize the Costs of Quality, specifically Incoming Rejects, Failures, and operational defects.Work with product support teams on component quality issues and supplier initiatives.Work directly with vendors under the control of the Lake Region Medical QMS. This involves travel to supplier sites so this person must be available to travel at short notice.Support implementation of initiatives such as "Supplied Data" and "Dock to Stock".Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.Develop and support Supplier Quality Engineering program.Review document and procedure changes for quality requirements and compliance with the quality system.Provide quality support for the disposition of material.Support the implementation of continuous improvement initiatives for productive ply with all work rules including those pertaining to safety, health, and quality.Provide leadership and guidance to QC Technicians who perform receiving inspection activities.Job Requirements Minimum Education:Bachelor's degree in Engineering. Master's degree strongly preferred. Six Sigma Black Belt Certified or Certified Quality Engineer preferred.Minimum Experience:7-10 years experience in Quality, Supplier Quality, Supply Chain or related process driven field.Specialized Knowledge:Negotiating, influence and leadership abilities. Computer knowledge: MS Excel, MS Word, MS Power Point, Minitab.Quality System Audits knowledge.Good manufacturing and documentation practices.Drawings and blueprints knowledge.Strong experience with ISO 13485,QSR, andor ISO9001 systemsASQ certified quality engineermanager desiredASQ or equivalent auditor certification desiredMust have the ability to interact professionally, with associates at all levels of the organization.Keyboarding required for inputting and analyzing data, memorandums and reports.Self-started with the ability to facilitate activities with little directionDeadline sensitive with a high degree of concentration.Attention to details.Must be able to work with diverse groups within the company.Must be able to think critically about technical matters that may impact upon the fit, form or function of Lake Region's product.High visual and tactile demand.Special Skills: Measurement and test equipment knowledge.Excellent communication (written and verbal) skills with internal and external customers. Presentation skills.Ability to work in a matrix organization, strong analytical skills. Problem solving and skills.Proven leadership, communication, and project management.Demonstrated ability to lead team activities. Strong ability to coach. Advanced problem solving skills. Strong communication, presentation, follow-through, and organizational skills. Ability to effectively work with coworkers and all levels of the organization

Created: 2025-02-21