Quality Engineer II

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:

Responsible for maintaining and improving the quality management system (QMS) and supporting the design, manufacture, and post-market quality of medical devices. This role involves independently leading quality projects, performing risk assessments, managing suppliers, investigating nonconformances, and driving CAPAs to closure. The QE II provides guidance to QE I-level engineers and Technicians, supports validation activities, and serves as a cross-functional liaison with Manufacturing, R&D, Regulatory, Engineering, and Supply Chain teams. This role requires strong analytical skills and the ability to interpret data to drive quality and business decisions, along with the capability to manage multiple priorities in a regulated, high-paced environment.

General Duties and Responsibilities:

• Lead investigations for complaints, nonconformances, and CAPAs, including root cause analysis and corrective action effectiveness evaluations.
• Independently manage quality engineering tasks on cross-functional project teams for new product development, product improvements, and validation activities.
• Provide support and guidance to QE I-level engineers and QA technicians; may assist in training or onboarding junior personnel.
• Author and execute validation protocols (IQ/OQ/PQ), test method validations, packaging validations, and equipment qualifications.
• Develop and maintain risk management documentation (e.g., design and process FMEAs) in accordance with ISO 14971.
• Support the EO sterilization validation and monitoring program, as applicable to assigned product families.
• Review and approve engineering change orders, risk assessments, and verification/validation documentation.
• Provide daily quality engineering support to manufacturing and production teams to ensure compliance with specifications and process controls.
• Analyze production quality data and lead initiatives to reduce scrap, improve yields, and minimize process variation.
• Assist in the development and approval of inspection methods, control plans, and sampling strategies for production processes.
• Participate in supplier quality activities, including audits, corrective actions, and performance monitoring.
• Support internal audits and external regulatory inspections (e.g., FDA, ISO, MDSAP) through document preparation, interview participation, and follow-up actions.
• Analyze data using statistical methods and tools (e.g., Minitab), monitor trends, and identify opportunities for process improvements.
• Review, write, and revise SOPs, work instructions, inspection methods, and quality plans.
• Participate in quality improvement initiatives and provide input to enhance product and process robustness.
• Perform other duties and responsibilities as assigned.
• May have dotted line supervision responsibility.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical field is required.
• 4-6 years of experience in a quality role in a regulated industry (medical device preferred).
• Demonstrated experience with complaint handling, project management, validation, supplier management, and risk management.
• American Society of Quality (ASQ) Certification (CQA, CQE, SSBB, etc.) preferred.
• Familiarity with FDA QMSR, EU MDR, MDSAP, ISO13485, and ISO 14971 is preferred.
• Hands-on experience with validation activities (IQ/OQ/PQ), test method validation, and inspection systems.
• Strong problem-solving and data analysis skills; experience with root cause tools (e.g. 5 Whys, Fishbone).
• Proficiency with MS Office; Minitab experience preferred.
• Must possess technical writing, project management and fundamental problem-solving skills.
• Ability to manage time and priorities with limited supervision.
• Experience as a Lead Auditor of quality management systems.
• Ability to travel up to 10% of the time.

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Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.