Supplier Quality Engineer — ISO & QC Excellence

Mt. Washington Pediatric Hospital; Fort Wayne (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

401k matching

Quarterly bonus

Tuition Reimbursement

Paid Time Off

Job summary

Fort Wayne Metals is seeking a Supplier Quality Engineer to ensure adherence to customer and company quality requirements. You will manage QC/QA for production and testing, evaluate suppliers, and lead audits to ISO13485, FDA 21 CFR Part 820, and AS9100.

This is a role focused on supplier collaboration and process improvements. Qualified candidates will have a BS in Engineering, ASQ CQE preferred, and experience with supplier quality systems and audits.

Qualifications

• Bachelor of Science in Engineering or related field required.
• ASQ CQE certification preferred.
• Experience with supplier quality management and audits.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, AS 9100 standards.

Responsibilities

• Manage quality control and assurance for production and testing; recommend changes.
• Apply customer and Fort Wayne Metals quality requirements; update docs.
• 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.
• Develop and maintain Approved Supplier List (ASL).
• Support supplier process validations and test methods.
• Review supplier inspection plans and control strategies.
• Ensure robust process controls for metallic wire manufacturing.

Skills

GD&T

Inspection methods

Statistical analysis

Process validation

Communication

Negotiation

Self-checking

Product knowledge

Stakeholder rapport

Education

Bachelor of Science in Engineering

Tools

IQ/OQ/PQ protocols

Job description

Fort Wayne Metals is seeking a Supplier Quality Engineer to ensure adherence to customer and company quality requirements. You will manage QC/QA for production and testing, evaluate suppliers, and lead audits to ISO13485, FDA 21 CFR Part 820, and AS9100.

This is a role focused on supplier collaboration and process improvements. Qualified candidates will have a BS in Engineering, ASQ CQE preferred, and experience with supplier quality systems and audits.