Electrochem, a subsidiary of Greatbatch, Ltd, is seeking a Sr. Supplier Quality Engineer. Electrochem specializes in customized rechargeable and non-rechargeable battery cells, battery packs, charging and docking stations, and power supplies for the portable medical market. 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. This position will also be responsible for performing GMP/ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance.
- Quality representative for Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives
- Develop, maintain and improve Electrochem’s supplier management program while assuring alignment and supporting Greatbatch Inc. Supply Chain Organization initiatives and policies
- Determine strategies for continuous improvement in supplier quality and supply chain metrics
- Manage supplier’s corrective actions system (investigation, documentation and implementation of corrective action and the verification of their effectiveness)
- 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
- Coordinate the disposition of non-conforming raw material
- 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.)
- Perform component qualifications, risk assessments, and first article inspections (as required) prior to the supplier implementing and/or performing the change
- 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
- Develop and conduct statistically designed experiments to determine sources of material / component variability so that product quality is maintained or improved
- Monitor and assure Electrochem’s supply chain activity and procedure set is compliant to applicable sections of FDA quality system regulation and ISO 13485 regulation.
- Support Greatbatch, Inc. Supplier Management activities
Greatbatch - 2 years ago
ElectroChem Incorporated was founded in 1986 with a strong reputation for successful problem solving in the field of fuel cells - a...