Quality Assurance Technician

Job Summary

We are seeking a detail-oriented and proactive Quality Assurance Technician to join our manufacturing team. In this role, you will be instrumental in ensuring that all products meet rigorous quality standards and comply with industry regulations. Your expertise will help maintain the integrity of our production processes, uphold ISO and GMP standards, and support continuous improvement initiatives. This position offers an exciting opportunity to contribute to high-quality manufacturing operations in a fast-paced environment, ensuring customer satisfaction and regulatory compliance.

Duties

• Conduct comprehensive quality inspections using precision measuring instruments such as height gauges, coordinate measuring machines (CMM), and vision inspection systems to verify dimensional accuracy and mechanical blueprint interpretation.
• Perform quality audits aligned with ISO 9001, ISO 13485, FDA regulations, and other regulatory standards to identify areas for improvement and ensure compliance across all production stages.
• Interpret manufacturing documentation, including production documents, technical drawings, and GD&T (Geometric Dimensioning & Tolerancing), to confirm adherence to quality specifications.
• Utilize calibration procedures for measuring instruments and ensure measurement accuracy through regular calibration checks.
• Collect and analyze data related to quality control metrics, non-conformance reports, and inspection results to support root cause analysis and corrective actions.
• Support manufacturing teams by providing guidance on quality standards in production, GMP practices, HACCP protocols (if applicable), and regulatory/legal compliance standards.
• Assist in the implementation of quality management systems (QMS) by documenting inspection results, maintaining records of quality audits, and supporting internal/external audits.
• Collaborate with cross-functional teams to improve quality assurance processes and ensure consistent application of quality systems throughout production.

Experience

• Proven experience in quality assurance within a manufacturing environment, preferably in medical devices or regulated industries such as pharmaceuticals or food processing.
• Strong knowledge of ISO standards (ISO 9001, ISO 13485), GMP (Good Manufacturing Practices), FDA regulations, and HACCP principles.
• Hands-on experience with calibration and use of measuring instruments including height gauges, dial indicators, vernier calipers, GMMs, and vision inspection systems.
• Familiarity with mechanical blueprint interpretation, GD&T principles, and dimensional measurements.
• Ability to perform quality audits effectively while analyzing data for trends and process improvements.
• Mechanical knowledge that supports understanding of manufacturing processes and product specifications.
• Basic math skills for measurement calculations and data analysis.
• Excellent attention to detail combined with strong analysis skills to identify deviations from quality standards promptly.

Join us in maintaining the highest levels of product excellence! Your dedication will directly impact our ability to deliver safe, reliable products that meet or exceed customer expectations while ensuring full compliance with all applicable regulatory requirements.

Pay: $52,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Retirement plan

Work Location: In person