Supplier Quality Engineer

Description

We're glad you're exploring our Supplier Quality Engineer position and want to share some of the details.

At Fort Wayne Metals, we specialize in producing top-quality wires, cables, and assemblies designed to enhance and safeguard lives. Our products are used in everything from our customers' stents and surgical robots to aircraft and automobiles. At our essence, we are thinkers, innovators, and problem solvers, leveraging our knowledge of materials to create customized solutions for our customers.

Join us in our dedication to making a tangible impact through our advanced materials and superior products.

The Supplier Quality Engineer will serve as a Supplier Quality Control (QC) and Supplier Quality Assurance (QA) resource for the Operations, Sales, Engineering, and Quality departments and to Suppliers to ensure adherence to Customer requirements, regulatory requirements, Fort Wayne Metals' (FWM) purchase order and quality system requirements.

Education & Experience Requirements

• Bachelor of Science degree in Engineering or related field and equivalent demonstrated skills and abilities required.
• American Society for Quality (ASQ) Certified Quality Engineer (CQE) or other recognized professional certification preferred.
• Six Sigma Black Belt certification preferred.

Job Responsibilities

• Work within the company policies and customer guidelines to manage the quality control and assurance aspects of production and testing. Make recommendations for changes as appropriate.
• Responsible for the application of Customer and FWM quality requirements. This includes updating procedures, work instructions, and forms and reviewing customer and FWM specifications.

Supplier Qualification & Development

• Evaluate and qualify new suppliers for metallic wire and related components.
• Conduct supplier audits to assess compliance with ISO 13485, FDA 21 CFR Part 820, AS 9100 and other applicable standards.
• Develop and maintain Approved Supplier List (ASL).
• Support supplier process validations (IQ, OQ, PQ) and test method validations (TMV).
• Review and approve supplier inspection plans, sampling plans, and control strategies.
• Ensure suppliers implement robust process controls for metallic wire manufacturing (e.g., tensile strength, surface finish, dimensional accuracy).

Compliance & Documentation

• Maintain supplier quality records, including audit reports, SCARs (Supplier Corrective Action Requests), and performance metrics.
• Ensure compliance to International Organization for Standardization (ISO), Good Manufacturing Practice (GMP), Food and Drug Administration (FDA), Purchasing controls and customer quality requirements and standards.
• Support regulatory audits and inspections.

Quality Issue Resolution

• Lead root cause analysis and corrective actions for non-conforming materials.
• Manage supplier-related CAPAs and drive timely closure.
• Collaborate with internal teams (R D, Manufacturing, Purchasing) to resolve quality issues.

Continuous Improvement

• Monitor supplier performance using KPIs (e.g., defect rates, on-time delivery).
• Implement Lean and Six Sigma methodologies to improve supplier processes.
• Train and mentor suppliers on quality requirements and best practices.
• Design and refine methods for process control, process improvement, testing and inspection. Conduct analysis, design test equipment and complete research to determine effectiveness of methods. Work with Quality Manager on change implementation.
• Review and revise raw material, indirect material, and packaging specifications in accordance with customer expectations, FWM's needs, and industry standards.
• Serve as a resource to supervisors, engineers, operations, and the Quality Team for problem identification, resolution, loss reporting and continuous improvement.
• Educate employees on the FWM quality policy, including creating materials and delivering training. Answer questions regarding company quality policy and technical issues.
• Lead and participate in internal, external, customer, and regulatory quality audits.
• Act as communication liaison to management regarding quality metrics, quality problems, trends, losses, and recommendations for quality improvement.
• Remain current on…