Auditor

Job Overview

We are seeking a highly motivated and detail-oriented Auditor to join our dynamic quality assurance team. In this role, you will be responsible for conducting comprehensive audits to ensure compliance with industry standards, regulatory requirements, and internal quality systems. Your expertise will help uphold the highest levels of product quality, safety, and efficiency across manufacturing processes. This position offers an exciting opportunity to contribute to continuous improvement initiatives and maintain rigorous quality standards within a fast-paced production environment.

Responsibilities

• Perform detailed quality audits across various manufacturing departments, ensuring adherence to ISO 9001, ISO 13485, GMP, and FDA regulations.
• Utilize precision measuring instruments such as calipers, micrometers, height gauges, and coordinate measuring machines (CMM) to verify dimensional accuracy and mechanical specifications.
• Conduct visual inspections using vision inspection systems and measure instruments to assess product conformity against technical drawings and quality standards.
• Interpret manufacturing documents, blueprints, mechanical drawings, and GD&T (Geometric Dimensioning & Tolerancing) specifications for accurate assessment of parts and assemblies.
• Collect and analyze data related to quality metrics, non-conformance reports, and audit findings to identify root causes and recommend corrective actions.
• Collaborate with production teams to ensure compliance with regulatory/legal standards and implement quality management system improvements.
• Document audit results thoroughly, prepare reports, and communicate findings clearly to management for continuous process enhancement.

Requirements

• Proven experience in quality assurance or quality control within a manufacturing environment.
• Strong knowledge of ISO standards (ISO 9001, ISO 13485), GMP (Good Manufacturing Practices), HACCP (Hazard Analysis Critical Control Point), and FDA regulations.
• Proficiency in using measuring instruments such as calipers, micrometers, height gauges, vision inspection systems, and coordinate measuring machines (CMM).
• Mechanical knowledge with the ability to interpret blueprints, mechanical drawings, and measurement data accurately.
• Familiarity with calibration procedures for measuring instruments like micrometers, calipers, height gauges, and vision systems.
• Excellent analysis skills with attention to detail in conducting quality audits and inspections.
• Basic math skills for data collection, measurement calculations, and dimensional analysis.
• Ability to interpret production documents and ensure compliance with quality standards in production processes.
• Strong understanding of regulatory/legal compliance standards applicable to manufacturing industries such as medical devices or pharmaceuticals.

Join us in ensuring the highest level of product integrity through meticulous auditing and continuous improvement!

Pay: $61.31 - $95.34 per hour

Expected hours: 42.0 per week

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Parental leave

Work Location: Remote