Quality Control Specialist

Job Overview

We are seeking a highly motivated and detail-oriented Quality Control Specialist to join our manufacturing team. In this vital role, you will ensure that all products meet stringent quality standards by conducting thorough inspections, measurements, and audits throughout the production process. Your expertise will help maintain compliance with industry regulations, ISO standards, and internal quality systems, contributing to the delivery of safe, reliable, and high-quality products. This position offers an exciting opportunity to apply your mechanical knowledge, precision measurement skills, and quality assurance experience within a dynamic manufacturing environment.

Duties

• Perform dimensional measurements using precision measuring instruments such as height gauges, coordinate measuring machines (CMM), and vision inspection systems to verify product specifications.
• Conduct comprehensive quality audits in accordance with ISO 9001, ISO 13485, GMP (Good Manufacturing Practices), and FDA regulations to ensure compliance with regulatory and legal standards.
• Interpret manufacturing and production documents, including mechanical blueprints and technical drawings, to confirm product conformity.
• Utilize calibration procedures for measuring instruments and ensure all tools meet calibration standards for accuracy.
• Analyze measurement data, identify deviations from quality standards in production, and document findings accurately for continuous improvement.
• Support manufacturing teams by providing guidance on quality standards in production and assisting with root cause analysis of quality issues.
• Assist in implementing and maintaining quality management systems (QMS) aligned with ISO standards and HACCP principles for food or pharmaceutical-related manufacturing processes.

Skills

• Proficiency with Calypso software or similar tools used for data collection and analysis in quality control processes.
• Strong understanding of ISO 13485 (medical device quality management), ISO 9001 (quality management systems), GMP, and HACCP standards.
• Experience operating coordinate measuring machines (CMM), vision inspection systems, height gauges, dial indicators, and other precision measurement instruments.
• Mechanical knowledge coupled with the ability to interpret mechanical blueprints and GDT (Geometric Dimensioning & Tolerancing) specifications.
• Familiarity with regulatory compliance standards such as FDA regulations for medical devices or pharmaceuticals.
• Ability to perform quality audits effectively and contribute to continuous improvement initiatives within a manufacturing setting.
• Basic math skills for data analysis, measurement calculations, and documentation accuracy.
• Strong attention to detail combined with excellent analysis skills to identify root causes of quality issues.
• Knowledge of manufacturing processes including dimensional measurements, precision machining, and quality inspection techniques.

Join us as a Quality Control Specialist where your expertise ensures our products meet the highest standards of safety, reliability, and excellence!

Pay: $45,000.00 - $55,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Work Location: In person