Auditor

Job Summary

We are seeking a highly motivated and detail-oriented Auditor to join our dynamic quality assurance team. In this pivotal role, you will be responsible for conducting comprehensive quality audits across manufacturing processes, ensuring compliance with industry standards and regulatory requirements. Your expertise will help uphold the highest levels of quality standards in production, driving continuous improvement and operational excellence. The ideal candidate will possess strong analytical skills, mechanical knowledge, and experience with precision measurement instruments to support our commitment to delivering superior products.

Duties

• Perform thorough quality audits using calibrated measuring instruments such as height gauges, micrometers, calipers, and vision inspection systems to verify dimensional accuracy and adherence to specifications.
• Analyze manufacturing processes and production documents to ensure compliance with ISO 9001, ISO 13485, GMP, HACCP, FDA regulations, and other relevant regulatory standards.
• Utilize calibration tools like coordinate measuring machines (CMM) and other precision measurement devices to conduct dimensional measurements and GD&T (Geometric Dimensioning & Tolerancing) assessments.
• Review quality systems and documentation to identify areas for improvement, ensuring alignment with quality management principles and regulatory/legal compliance standards.
• Conduct regular quality audits across production lines, focusing on quality control (QC) and quality assurance (QA) practices within manufacturing environments.
• Collect and analyze data related to quality inspections, measurement results, and process performance to support root cause analysis and corrective actions.
• Collaborate with cross-functional teams to interpret mechanical blueprints, manufacturing specifications, and production documents for accurate quality assessment.

Qualifications

• Proven experience in quality assurance or quality control within a manufacturing setting, with a strong understanding of quality systems such as ISO 9001, ISO 13485, GMP, or FDA regulations.
• Proficiency in using precision measuring instruments including height gauges, micrometers, calipers, vision inspection systems, and coordinate measuring machines (CMM).
• Mechanical knowledge with the ability to interpret mechanical blueprints and technical drawings accurately.
• Familiarity with regulatory/legal compliance standards relevant to manufacturing environments.
• Strong analysis skills with the ability to interpret data collected from various measurement tools and inspection processes.
• Basic math skills for measurements and data analysis; experience with GD&T principles is highly desirable.
• Excellent attention to detail combined with effective communication skills for documenting findings and collaborating with team members.
• Knowledge of Calypso software or similar calibration management tools is a plus; familiarity with ISO standards such as ISO 13485 and ISO 9001 is preferred.

Join us in ensuring the highest quality standards in our manufacturing processes! Your expertise will directly contribute to delivering safe, reliable products that meet rigorous industry requirements while supporting continuous improvement initiatives across our organization.

Pay: $83,127.86 - $100,110.98 per year

Benefits:

• Dental insurance
• Flexible schedule

Work Location: Remote