Delsys Technologies is seeking a dedicated Quality Engineer to ensure the safety, efficacy, and regulatory compliance of our innovative medical devices. This role involves collaborating with cross-functional teams to maintain high-quality standards in a dynamic healthcare environment.

At Delsys Technologies, we are at the forefront of developing advanced medical devices that enhance patient care and clinical outcomes. As a Quality Engineer, you will play a pivotal role in upholding the integrity of our products from design to deployment.

Your responsibilities will include developing and implementing quality control processes, performing risk assessments, and ensuring compliance with stringent regulatory requirements such as FDA 21 CFR Part 820 and ISO 13485. You will conduct internal audits, manage supplier quality, and lead investigations into quality issues, utilizing tools like FMEA and Six Sigma methodologies.

Collaborating with R&D, manufacturing, and regulatory affairs teams, you will contribute to the continuous improvement of our quality management system. This position requires a proactive approach to identifying potential risks and implementing preventive measures to safeguard product reliability and patient safety.

If you are passionate about quality in healthcare and thrive in a fast-paced, innovative setting, join us to make a tangible impact on medical technology.

• Bachelor's degree in Engineering, Quality Assurance, or a related field; advanced degree preferred
• Minimum of 3-5 years of experience in quality engineering within the medical devices industry
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards for medical devices
• Proficiency in quality management systems, risk assessment, and statistical analysis tools
• Strong analytical skills and attention to detail for conducting audits and root cause analysis
• Excellent communication skills to interface with regulatory bodies and internal stakeholders
• Experience with validation processes, CAPA (Corrective and Preventive Actions), and process improvements

• Competitive monthly salary range with performance-based incentives
• Comprehensive health, dental, and vision insurance coverage
• 401(k) retirement plan with company matching
• Generous paid time off and flexible work arrangements
• Opportunities for professional development and certifications in quality assurance
• Collaborative and innovative work environment focused on advancing healthcare technology