Precision Quality Process Inspector – ISO 13485 & GMP

Xodus Medical Inc.; New Kensington (Westmoreland County); On-site; USD 52,000 - 76,000; Full time

Job summary

Xodus Medical Inc. seeks a meticulous Quality Process Inspector to uphold QA standards in our manufacturing environment, verifying measurements, interpreting drawings, and supporting continuous improvement across processes.

You will perform ISO 13485, GMP, and FDA-compliant audits, conduct in-process testing, and collaborate with production teams to maintain product integrity and regulatory compliance.

Qualifications

• Meticulous attention to detail and measurement accuracy.
• Strong knowledge of ISO 13485 and GMP requirements.
• Ability to interpret technical drawings and manufacturing documents.
• Experience performing quality audits in manufacturing settings for compliance.
• Ability to analyze data for trend identification and defect detection.
• Excellent communication to report findings across departments.
• Strong organizational skills to maintain documentation and records.
• Mechanical aptitude relevant to QA inspections and calibration.

Responsibilities

• Conduct comprehensive quality inspections to verify process specifications.
• Interpret drawings and instructions to ensure correct assembly and production steps.
• Perform ISO 13485, GMP, and FDA-compliant audits to identify non-conformances and corrective actions.
• Perform in-process testing in a laboratory setting.
• Collaborate with manufacturing teams to ensure adherence to quality standards and regulatory compliance.
• Assist in developing and implementing quality management systems and documentation control.

Skills

Measurement tools

ISO 13485/GMP

Technical drawings

Quality audits

Data analysis

Communication

Organization

Mechanical basics

Tools

Calipers

Micrometers

Gage blocks

Job description

Xodus Medical Inc. seeks a meticulous Quality Process Inspector to uphold QA standards in our manufacturing environment, verifying measurements, interpreting drawings, and supporting continuous improvement across processes.

You will perform ISO 13485, GMP, and FDA-compliant audits, conduct in-process testing, and collaborate with production teams to maintain product integrity and regulatory compliance.