Our client, located in Plymouth, MN, is a leading medical device manufacturer. Its Quality Group is seeking an experienced Supplier Quality Engineer. The 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.
Essential Functions of the Job
- Represent Quality interests for Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives.
- Develop, maintains and improves the supplier management program while assuring alignment and support of the Supply Chain Organization initiatives and policies.
- Determine strategies for continuous improvement in supply chain metrics.
- Perform GMP/ISO audits on suppliers, propose improvements to their quality system, and track the closure of any audit related non-conformance.
- Manage supplier’s corrective actions system such as investigation, documentation and implementation of corrective actions, and the verification of their effectiveness.
- Design and specify inspection methods, tools, and test equipment to ensure product quality and design integrity are appropriately maintained.
- Implement appropriate inspection sampling plans using statistical methods.
- Coordinate the disposition of non-conforming raw material.
- Manage the suppliers’ product and process change notification (PCN) system, including coordinating biocompatibility assessments.
- Review and approve changes to supplier related documents (Procedures, drawings, etc.)
- Perform component qualifications, risk assessments, and first article inspections (as required) prior to the supplier implementing or performing the change.
- Participate in supplier’s design review, product validation, and design verification Risk Management plans/reports (dFMEA, pFMEA)
- Perform risk analysis for existing and new raw materials and components.
- Develop and conduct statistically designed experiments to determine sources of material and component variability so that product quality is maintained or improves.
- Monitor and assure the supply chain activity and procedure set is compliant to applicable sections of FDA quality system regulation and ISO13455 regulation
- Support the company’s Supplier Quality Management initiatives
- Education/Experience: Bachelor’s degree in related field. Master’s degree in technical field preferred. Six Sigma Black Belt Certified or Certified Quality Engineer preferred. 3 years of experience in ISO9000 and/or ISO13485 and FDA Quality Systems experience.
- Specialized knowledge needed for performance of job: Computer knowledge of Oracle, QCBD, and Minitab. Knowledge of Quality System Audits, FDA, good manufacturing and documentation practices, drawing and blueprints, and measurement and test equipment.
- Special Skills: Strong presentation, problem solving, communication, negotiations and leadership skills.