Quality Engineer - On-Site

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
• 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