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Adheres to Company Core Beliefs and all safety and quality requirements
Quality representative for Supplier Quality activities, both troubleshooting / CAPA and continuous improvement initiatives
Develop, maintain and improve the supplier management program while assuring alignment and supporting the Companu s 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
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 Company Supplier Management activities
Perform other duties as assigned
Education / Certification
Bachelor’s degree in Engineering. Master’s degree preferred. Six Sigma Black Belt Certified or Certified Quality Engineer preferred.
5 - 8 years of experience in Quality, Supplier Quality, Supply Chain or related process driven field.
Skills / Competencies
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.
Measurement and test equipment knowledge.
Excellent communication (written and verbal) skills with internal and external customers.
Ability to work in a matrix organization, strong analytical skills.
Problem solving and skills.
Proven leadership, communication, and project management.
Effective Problem Solve
Out of the Box Thinker
10 15% travel
Light work : Exerting up to 20 pounds of force occasionally, and / or up to 10 pounds of force frequently, and / or lift, carry, push, pull, or move objects. Sitting at a desk.