Quality Process Auditor

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

We are seeking a meticulous and detail-oriented Quality Process Inspector to uphold the highest standards of quality assurance within our manufacturing environment. The ideal candidate will possess a strong background in quality control, quality systems, and manufacturing processes, with a focus on ensuring compliance with industry standards and regulatory requirements. As a Quality Process Inspector, you will play a critical role in maintaining product integrity, verifying measurements, and supporting continuous improvement initiatives to deliver superior products to our clients.

Duties

• Conduct comprehensive quality inspections to verify compliance to process specifications.
• Interpret manufacturing documents, instructions, and technical drawings to ensure correct assembly and production processes are followed.
• Perform quality audits in accordance with ISO 13485, GMP (Good Manufacturing Practices), and FDA regulations to identify non-conformances and recommend corrective actions.
• Perform in-process testing of products in a laboratory environment.
• Collaborate with manufacturing teams to ensure adherence to quality standards in production while supporting regulatory/legal compliance standards.
• Assist in the development and implementation of quality management systems, including documentation control and process validation efforts.

Skills

• Knowledge of usage of tools such as measurement equipment and mechanical test equipment.
• Strong understanding of ISO standards including ISO 13485 (medical devices) and GMP regulations.
• Proficiency in interpreting technical drawings, and manufacturing documents accurately.
• Experience conducting quality audits within manufacturing environments with an emphasis on compliance verification.
• Mechanical knowledge combined with familiarity with measurement instruments.
• Ability to analyze data effectively using basic math skills for trend analysis and defect identification.
• Excellent communication skills for reporting findings clearly and collaborating across departments.
• Strong organizational skills with attention to detail necessary for maintaining high-quality standards in production processes.

Join our team as a Quality Process Inspector if you are committed to excellence in manufacturing quality assurance—helping us deliver safe, reliable products that meet the strictest industry standards!