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.

Essential Job Duties and Responsibilities

• Assure compliance with FDA Quality Systems Regulation, ISO Standards and SOP’s as defined by Nordson MEDICAL (NH), Inc. policies, practices and procedures.
• Apply Quality Engineering techniques on new or existing products. Assure all products meet or exceed customer requirements.
• Represent Quality in production process efforts, quality planning, FMEA and Risk Analysis.
• Lead IQ, OQ, PQ validation activities including the drafting, review and execution of protocols.
• Lead customer validation activities including PPAP and first article inspection.
• Receive, investigation, and implement corrective action on customer complaints.
• Lead and provide direct support to customers on general inquiries or troubleshooting.
• Review, investigation, and disposition MRB or nonconforming product.
• Review, process, and approve specifications, engineering change requests, and process deviations.
• Lead corrective and preventive action initiatives.
• Support or lead internal or external quality system audits.
• Train and support QC inspectors on proper measurement methods and quality system objects.
• Mentor and guide other employees.
• Maintain effective working relations, communications, and feedback with all other departments.
• Participate and lead continuous improvement teams to support inspection reduction, waste savings initiative, or similar continuous improvement activities.
• Independently perform statistical analysis to identify improvement opportunities.
• Other duties as assigned.

Education and Experience Requirements

• BS in engineering (Plastics, Chemical, Mechanical engineering preferred), other engineering disciplines considered.
• Minimum 5 years of experience in Quality Engineering.
• Prior experience working in the medical field preferred.
• Statistical knowledge or experience required. Experience with Minitab or other statistical software required.
• Six Sigma or Lean experience desired.
• Fluently read, write, and speak English.

Skills and Abilities

• Write clearly and concisely to communicate technical knowledge.
• Establish collaborative working relationships.
• Ability to work in a fast-paced environment and handle multiple projects simultaneously.
• Able to act independently without significant oversite.
• Statistical analysis.
• Root cause analysis and corrective action.
• Risk management
• Validations.
• Lean six sigma tools.
• Metrology experience.
• MSA.
• Control plan, process flow analysis.

Working Conditions and Physical Demands

Physical

• Must be able to lift 25 lbs.
• Requires visual and tactile acuity, and dexterity (fine motor skills).
• Must wear proper PPE for specific hazards.

Environment

• Office environment with significant time on the manufacturing floor. Manufacturing floor is a controlled environment with proper gowning required for entry.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Travel Required

 Estimated 10%

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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.