We’re looking for a talented Quality professional who is passionate about building high-performing quality systems and ready to contribute to life-saving products that truly matter. The Quality Engineer collaborates with various departments to drive and maintain the highest possible quality performance. This person will leverage quality tools, root cause analysis, and problem-solving expertise to shape and continuously improve the company’s quality systems and culture.

Responsibilities:

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure full compliance with ISO 9001, FDA, and other applicable regulatory standards.
• Manage internal audits, quality documentation, and complaint handling processes to uphold product and process integrity and drive systemic improvement.
• Analyze customer feedback and quality data to identify trends, lead root cause investigations, implement corrective actions, and evaluate their long-term effectiveness.
• Champion a culture of quality, providing guidance, training, and communication across departments to promote ownership and alignment with best practices.
• Oversee supplier quality, including qualification, auditing, and incoming material inspection, ensuring supplier performance supports operational standards.
• Utilize Lean, Six Sigma, and other continuous improvement methodologies to reduce defects, optimize processes, and enhance product and service quality.
• Establish and track key performance indicators (KPIs) to assess quality effectiveness and drive data-informed decision-making across the organization.

Requirements:

• Bachelor’s degree in Engineering or a related field; advanced degree or quality certification(s) a plus.
• 3–5 years of experience in Quality Engineering within an ISO 9001 environment.
• Proven ability to communicate across departments, manage cross-functional projects, and lead quality initiatives.
• Strong skills in problem-solving, root cause analysis, and process mapping.
• Experience with Lean and/or Six Sigma (Green or Black Belt preferred).
• Proficient in Microsoft Office, especially Excel; familiarity with CRM/ERP systems a plus.