Quality Assurance Technician with 21 CFR Part 111 Dietary Supplement Experience

Overview We are seeking a highly motivated and detail-oriented Quality Assurance Technician with experience in 21 CFR Part 111 regulations to join our dynamic manufacturing team. In this vital role, you will ensure that all products meet rigorous quality standards and comply with industry regulations, including FDA guidelines for dietary supplements and nutritional products. Your expertise will help uphold our commitment to delivering safe, high-quality products to consumers worldwide. This position offers an exciting opportunity to contribute to continuous improvement initiatives within a fast-paced, quality-driven environment. Responsibilities Conduct comprehensive quality inspections using precision measuring instruments such as calipers, micrometers, and vision inspection systems to verify product specifications and tolerances. Perform routine quality audits in accordance with

ISO 13485, ISO

9001, and CGMP standards, identifying areas for improvement and ensuring compliance with regulatory requirements. Utilize calibration tools and coordinate measuring machines (CMM) to validate measurement accuracy across manufacturing processes. Collect and analyze data related to product quality, manufacturing processes, and inspection results to support root cause analysis and corrective actions. Assist in the development, implementation, and maintenance of quality systems aligned with FDA regulations (including 21 CFR Part 111) and HACCP principles for food safety management. Support internal and external quality audits by preparing documentation, participating in assessments, and ensuring adherence to ISO standards. Collaborate with manufacturing teams to resolve quality issues promptly, ensuring consistent product integrity through effective quality control measures. Qualifications Proven experience working within FDA-regulated environments, specifically with 21 CFR Part 111 compliance for dietary supplements or similar sectors. Strong knowledge of

ISO 13485, ISO 9001, HACCP, CGMP

standards, and quality management systems. Proficiency in using precision measurement tools such as calipers, micrometers, vision inspection systems, and coordinate measuring machines (CMM). Familiarity with Calypso software or similar data collection platforms is a plus. Excellent analysis skills with the ability to interpret complex data sets and identify trends or deviations. Experience conducting quality audits and implementing corrective actions within a manufacturing setting. Strong understanding of quality assurance principles related to manufacturing processes, quality control procedures, and inspection techniques. Effective communication skills to collaborate across departments and ensure compliance with regulatory standards. Join us in our mission to deliver safe, high-quality products by ensuring rigorous adherence to industry standards! Pay range is based depends on experience. Minimum 2-5 years of direct experience in dietary supplement manufacturing or quality systems under 21 CFR Part 111.

Pay:

$60,000.00 - $100,000.00 per year

Benefits:

401(k) Dental insurance Health insurance

Work Location:

In person