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. 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.

• Education/Experience: Education/Experience: Bachelor’s degree in Engineering. Master’s preferred. Six Sigma Black Belt Certified Quality Engineer preferred. 5-8 years of experience in Quality, Supplier Quality, Supply Chain or related process driven field.

SPECIALIZED KNOWLEDGE/SKILLS:

• Negotiating, influence and leadership abilities
• Computer knowledge: MS Excel, MS Word, MS PowerPoint, 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.
• Presentation skills
• Ability to work in a matrix organization, strong analytical skills.
• Problem solving and skills
• Proven leadership, communication, and project management.
• Quality Driven
• Teamwork Centered
• Self-Driven
• Relentless Communicator
• Customer Champion
• Effective Problem Solver
• Out of the Box Thinker
• Detailed Oriented

ESSENTIAL FUNCTIONS INCLUDE

• Adheres to the company’s 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 company in 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.
• Supports Greatbatch, Inc. Supplier Management activities
• Performs other functions as required.

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