Quality Engineer

Join an innovative medical-device team focused on improving patient outcomes through engineering excellence and regulatory precision. The Quality Engineer will play a key role in ensuring compliance, reliability, and performance of life-changing technologies — supporting both product development and ongoing manufacturing operations.

What You’ll Do

• Develop and maintain quality controls, processes, and analytical methods to ensure conformance to product specifications.
• Lead verification and validation (V&V) testing, including protocol design, execution, data analysis, and reporting.
• Support design control activities and cross-functional reviews for new product development and significant design changes.
• Drive statistical analysis and data-driven decision making for process stability and product quality.
• Collaborate with manufacturing and suppliers to maintain conformance and improve assembly, testing, and documentation practices.
• Support supplier qualification , incoming inspection, and process improvement initiatives.
• Participate in risk management activities (ISO 14971) and ensure compliance with QMS and regulatory standards.
• Support internal and external audits (FDA, ISO), nonconformance investigations, and CAPA initiatives.
• Analyze field issues and deviations, perform root cause analysis, and implement effective corrective actions.

What You’ll Bring

• Bachelor’s degree in Biomedical, Mechanical, Chemical, or related Engineering field .
• 3+ years of experience in a medical device quality engineering role.
• Working knowledge of FDA QSR, ISO 13485, ISO 14971 , and risk-based quality systems.
• Hands-on experience with verification testing, statistical analysis, and process validation .
• Strong communication skills — able to produce clear reports, present findings, and collaborate across disciplines.
• Proficiency with Excel, Minitab, MATLAB , or equivalent analytical tools.
• Detail-oriented, organized, and proactive in driving continuous improvement.