Senior Quality Engineer

Nordson Corporation • Allen, TX

34d

About The Position

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment. Summary of the role As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected. Summary The Senior Quality Engineer is responsible for maintaining and improving the Quality Management System (QMS) across the product lifecycle-from design and development to manufacturing and post-production. This role leads CAPA and risk assessment activities, supports supplier quality programs, manages engineering projects, and ensures compliance with regulatory standards through audits and validations.

Requirements

• Bachelor's degree in engineering, science, or related technical field.
• Minimum 8 years of quality engineering experience in regulated industries (medical device or pharmaceutical preferred).
• Strong knowledge of analog/digital circuits, embedded software, and hardware systems.
• Experience with ISO 13485, ISO 14971, FDA QSR, IEC 60601, and related standards.
• Proficiency in statistical tools and software (Minitab preferred).
• Excellent communication, technical writing, and project management skills.
• Ability to travel up to 10%.

Nice To Haves

• ASQ certifications (CQE, CQA) and Six Sigma Green/Black Belt preferred.

Responsibilities

• Lead CAPA investigations and risk assessments for new and existing products.
• Support daily manufacturing activities and resolve line issues.
• Develop and maintain quality systems, procedures, and documentation.
• Provide technical support for incoming inspection and lot release testing.
• Manage customer complaints and non-conformance investigations.
• Lead internal and external audits (FDA, ISO, MDD).
• Oversee supplier quality activities including audits and corrective actions.
• Support engineering teams in product development and process improvements.
• Conduct statistical analysis, validation testing, and Gage R&R studies.
• Mentor junior quality staff and provide training as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Machinery Manufacturing
• Number of Employees: 5,001-10,000 employees