Quality Assurance Engineer

At Confluent Medical, we help design and manufacture high-quality, life-saving medical devices. As a Quality Assurance Engineer, you will be the bridge between engineering, manufacturing, and regulatory compliance. You will ensure that our production processes are stable, our products meet rigorous standards, and our operations remain safe and efficient. This is an opportunity to take ownership of quality processes, collaborate with cross-functional teams, and see the direct impact of your work on patient safety.

What Success Looks Like in This Role

On a day-to-day basis, you will support our manufacturing value streams to keep production running smoothly and safely. You will investigate quality deviations, collaborate with suppliers and customers to resolve issues, and use statistical tools to analyze data and improve processes. You will regularly review Non-Conformance Reports (NCRs), identify root causes, and coordinate presentations for our oversight review board.

Over time, you will become a key driver of continuous improvement. You will lead validation efforts for new equipment or processes, revise critical manufacturing documents, and help prepare our site for external regulatory audits. Your success is measured by the reliability of our manufacturing lines, the timely resolution of quality issues, and your ability to foster a collaborative culture of quality and safety.

Your Key Responsibilities

• Review and resolve Non-Conformance Reports (NCRs), and lead root-cause investigations for internal Corrective and Preventive Actions (CAPAs).
• Investigate and manage customer complaints and Supplier Corrective Action Requests (SCARs).
• Partner with manufacturing teams to diagnose, troubleshoot, and resolve day-to-day production and quality system issues.
• Use statistical analysis tools to generate reports and provide guidance on sample size requirements, process capability, regression, tolerance intervals, and ANOVA.
• Create, review, and approve validation protocols, technical reports, and standard operating procedures.
• Update quality documentation and train manufacturing personnel on revised procedures and quality standards.
• Interface directly with customers and suppliers regarding quality issues, project requirements, and engineering change requests.
• Support the hosting of external customer and regulatory agency audits.
• Maintain high standards of safety by ensuring personal and company compliance with all environmental, health, and safety regulations.

What You Bring to the Team

Must-Have Qualifications

• Bachelor of Science in an engineering discipline, or an equivalent combination of education and hands-on experience.
• At least 5 years of related engineering experience with a strong focus on quality systems or manufacturing support.
• Practical experience conducting statistical data analysis using Minitab and advanced features in Microsoft Excel.
• A solid understanding of core engineering fundamentals and experimental techniques.
• Clear written and verbal communication skills in English, with the ability to write structured technical reports.
• A strong commitment to workplace safety and experience following safety standard operating procedures.

Nice-to-Have Qualifications

• Prior engineering experience within the medical device manufacturing industry.
• Familiarity with ISO 13485 or FDA quality system regulations.
• Experience assisting with external audits or notified body inspections.

Join Our Team

If you are a detail-oriented engineer who is passionate about quality, safety, and making a tangible difference in the medical field, we would love to hear from you. Apply today to start a conversation with our hiring team.