Supplier Quality Engineer
Our client is a leading OEM supplier of products and services for medical devices and procedures.
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.