Greatbatch Medical is seeking a Senior Supplier Quality Engineer. The primary purpose of this position is to support the development and maintain a risk-based supplier management process, lead critical supplier-related improvement projects, and support daily supplier activities (non-conformances, CAPA, requests for change, etc). This position will support the QiG group from the supplier quality perspective (supplier search, development, maintenance and performance).
Essential Functions of the Job
- Support the Global Supplier Quality Organization to develop, implement and maintain the enterprise supplier management process (SMP)
- Determine strategies for continuous improvement in supplier quality and supply chain metrics
- Quality representative for Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives
- Manage supplier’s corrective actions system (investigation, documentation and implementation of corrective action and the verification of their effectiveness)
- Develop and conduct statistically designed experiments to determine sources of material / component variability so that product quality is maintained or improved
- Coordinate the disposition of non-conforming raw material
- Performs component qualifications/first article inspections (FAI) as a consequence of GB’s new product development and Change Control processes
- Perform component qualifications, risk assessments, and first article inspections (as required) prior to the supplier implementing and/or performing the change
- Design and/or specify inspection methods, tools, and test equipment to ensure product quality and design integrity are appropriately maintained. Also implements appropriate inspection sampling plans using statistical methods
- Perform GMP/ISO audits on suppliers, proposes improvements to their quality system and track the closure of any audit related non-conformance
- Manages the suppliers’ product and process change notification (PCN) system, including coordinating biocompatibility assessments
- Review and approve changes to supplier related documents (procedures, drawing, etc.)
- Participates in supplier’s design review, product validation, design verification, Risk Management plans/reports (dFMEA, pFMEA)
- Performs risk analysis for existing and new raw materials / components
- Education: Bachelor’s degree in Engineering, Business, Procurement or Materials. Masters degree preferred. Six Sigma Black Belt Certified or Certified Quality Engineer preferred.
- Experience: 7 - 10 years of experience in Quality, Procurement or related process driven field.
- Specialized knowledge needed for performance of job: Strong negotiating, influence and leadership abilities. Experience/knowledge of inventory management, contract management and execution of supplier management practices.
- Special Skills: Excellent leadership and communication (written and verbal) skills. Strong analytical skills, ability to drive to the root cause of problems and determine solutions. Ability to define a project and direct teams through execution.
Greatbatch - 17 months ago