Quality Engineer

Company Overview Built to Last. Built for You. Built by Boyd embodies a steadfast commitment to delivering durable, reliable, and high-quality products tailored to our customers' needs. With over sixty years of expertise in design and manufacturing, we take pride in craftsmanship and innovation within the dental industry, serving professionals worldwide. Our company is proud to hold certifications including FDA and

ISO 13485

2016, ensuring our products meet rigorous quality standards. Job Overview We are seeking a passionate and detail-oriented Quality Engineer to join our dynamic team. In this role, you will drive quality excellence across our manufacturing processes, ensuring compliance with industry standards and regulations. Your expertise will help uphold our reputation for durability and reliability by implementing robust quality systems, conducting audits, and fostering continuous improvement initiatives. This is an exciting opportunity to contribute to a company dedicated to craftsmanship and customer satisfaction. Duties Develop, implement, and maintain comprehensive quality management systems aligned with

ISO 13485, ISO 9001, FDA

regulations, HACCP, CGMP, and other relevant standards. Lead internal and external quality audits to verify compliance with regulatory requirements and company policies. Perform thorough quality inspections and control checks throughout the manufacturing process to identify defects or deviations early. Analyze quality data to identify trends, root causes of issues, and opportunities for process improvements. Collaborate with cross-functional teams on project management initiatives aimed at enhancing product quality and efficiency. Ensure adherence to quality assurance protocols during product development, production, and post-market surveillance. Provide training on quality systems, inspection procedures, and regulatory compliance to team members. Requirements Proven experience working within manufacturing environments with a strong understanding of quality control and assurance practices. Familiarity with

ISO 13485

(medical devices), and FDA regulations (21 CFR Part 820). Demonstrated ability to conduct comprehensive quality audits and inspections effectively. Strong analysis skills with the ability to interpret data and implement corrective actions promptly. Excellent project management skills with a proactive approach to continuous improvement initiatives. Effective communication skills for training teams and collaborating across departments. Bachelor's degree in Engineering, Quality Management, or a related field is preferred; relevant certifications are a plus. Join us in maintaining the highest standards of quality as we continue to innovate and serve dental professionals worldwide!

Pay:

$69,278.91 - $80,000.00 per year

Benefits:

401(k) matching Dental insurance Flexible spending account Health insurance Vision insurance

Work Location:

In person