Supplier Quality Engineer

FORT WAYNE METALS in; Fort Wayne (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid Time Off

Annual Bonus

401k matching

Tuition reimbursement

Job summary

Fort Wayne Metals is seeking a Supplier Quality Engineer (Administrative) to support Operations, Sales, Engineering, and Quality. You will manage supplier quality activities, update procedures, review specifications, and drive improvements across our supplier base.

The role requires a BS in Engineering with CQE preferred, and involves audits, process validation support, and collaboration with internal teams to ensure product quality and regulatory alignment.

Qualifications

• Bachelor of Science degree in Engineering or related field.
• ASQ CQE or similar certification preferred.

Responsibilities

• Manage supplier quality control and assurance for production and testing.
• Review and update customer and Fort Wayne Metals quality requirements and procedures.
• Evaluate and qualify new suppliers for metallic wire and components.
• Conduct supplier audits to ensure ISO 13485, FDA 21 CFR Part 820, AS 9100 compliance.

Skills

Quality systems

Supplier audits

ISO 13485

FDA 21 CFR 820

Education

B.S. in Engineering

CQE certification preferred

Tools

IQ/OQ/PQ

Job description

Supplier Quality Engineer (Administrative)

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.

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.
• 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.
• 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 developments in quality testing methodologies including technology enhancements; attend periodic seminars, forums, and meetings; corrective action verification.
• Perform other duties as requested by management.

Skills Needed

• Proficient in GD&T, inspection methods, and statistical analysis.
• Familiarity with process validation protocols (IQ/OQ/PQ).
• Excellent communication and negotiation skills.
• Capable of self-checking for completeness and accuracy of work produced.
• Ability to learn and understand key product characteristics and machine/process capabilities.
• Ability to effectively establish rapport (internally & externally) to present information, influence change and respond to questions from suppliers.

Working Conditions & Physical Requirements

• Fast paced office environment.
• Work hours consist of 45 hours per week.
• Overtime may sometimes be necessary.
• National and/or international travel is expected (25%).
• Must be able to travel between various facilities.
• Majority of time spent at desk working on computer.
• Must be able to access all areas of operation, including second floors.
• Occasional lifting up to 50 pounds.
• Some time is spent standing, walking, lifting, and bending.
• Maneuver around, under, and about factory/laboratory equipment on a regular and continuous basis.

Benefits & Wellness Resources

The health and wellbeing of Fort Wayne Metals is a critical part of our culture. In addition to offering medical, dental, vision, life, and disability insurance options to suit your needs, we'd like to share some of the other fundamental resources that make Fort Wayne Metals a premier place to work:

Physical Wellness

• Parkview Wellness Coach
  • Ready to assist with your physical and nutritional wellness needs.
• 4 onsite gym locations as well as discounts for regional gym facilities
• From pickleball tournaments, sponsored races and sports leagues, to participating in the YMCA's Corporate Challenge, we have a variety of fun ways to stay active.
• When You Need to Talk
  • 5 sessions of counseling are available to you and all members of your immediate household at no cost.
• Relaxing Time-Off
  • Qualify for Paid Time Off and Holiday Pay on your first day of employment.
• Epic Events
  • From TinCaps Night to family days at the zoo, we offer multiple activities throughout the year for employees and their families.
• Employee Resource Group
  • A voluntary, employee-led group formed to bring employees together and centered around a common interest or identity.

Professional Wellness

• Grow Your Career
  • We offer many opportunities to continue your development and growth.
• Performance Feedback
  • Receive regular and constructive feedback from your manager and peers to help you grow and improve.
• Annual Profit Sharing & 401k matching
  • Dropping dollars into your 401k. When you contribute 7%, we'll contribute 3.5%.
• Quarterly Bonus
  • When we perform well, everyone benefits! Receive discretionary bonuses each quarter based on company performance.
• Tuition Reimbursement
  • Getting your first degree? Great! Whatever your major, we'll help pick up the tab!
• Your Money Line
  • Employer-provided 1:1 financial guidance, education, & tools – so you can stress less about money and enjoy greater stability & confidence.

There are many reasons to apply for this position, and these are just a few.Join us!

Notice to Employees and Applicants:

This job position may require access to controlled technology or technical data; applicant must be a candidate for export licensing and willing to participate in export licensing, if required.

As an Equal Opportunity Employer, Fort Wayne Metals Research Products LLC is proud to be committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or pregnancy and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Fort Wayne Metals is an equal opportunity employer fully committed to achieving a diverse workforce and complies with all Federal and Indiana State laws, regulations, and executive orders regarding non-discrimination.

Fort Wayne Metals Research Products LLC is committed to providing access and reasonable accommodation in its services, activities, programs, and employment opportunities in accordance with the Americans with Disabilities Act and other applicable laws. If reasonable accommodation is needed to participate in the job application, interview process, or to perform essential job functions, please contact [e-mail] .

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