Quality Process Auditor

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!

Work Location: In person