Quality Process Auditor

Job Summary

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!

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience:

• Quality Inspection: 1 year (Required)

Ability to Commute:

• New Kensington, PA 15068 (Required)

Work Location: In person