Quality Engineer II

Nordson; Salem (AL); On-site; USD 85,000 - 120,000; Full time

Job summary

Nordson MEDICAL is seeking an experienced quality professional to join our team in the United States. The role focuses on ensuring compliance with GMP, ISO 13485, and FDA standards while leading root-cause investigations, CAPA activities, and quality system improvements across manufacturing operations.

You will design and document gage R&R studies, support SOP training, and drive cost reductions through COPQ initiatives.

Qualifications

• Bachelor's degree in engineering or related discipline; may substitute for experience.
• Minimum of 5 years related experience in medical device industry.
• Knowledge of ISO 13485:2003, GMP, FDA, QSR.
• Strong root-cause investigation and problem-solving in manufacturing.
• Mechanical aptitude with manufacturing experience.

Responsibilities

• Ensure manufacturing operations follow GMP, GDP, ISO 13485 and FDA standards.
• Lead root-cause analysis, CAPA and corrective actions.
• Design, execute and document gage R&R studies.
• Support training on SOPs and QA documents (SOPs, PIs, MAPs, QAPs).
• Lead process improvement events to reduce COPQ.
• Reduce scrap and manufacturing waste across product lines.
• Quality Representative for MRB and SCAR processes.
• Investigate customer complaints and supplier SCARs.
• Prepare quality deliverables and engineering studies as needed.
• Implement SPC and lean QMS initiatives.
• Eliminate all escapes to the customer; target zero.

Skills

Root-cause analysis

Problem solving

Manufacturing experience

Quality system knowledge

Education

Bachelor's degree in engineering or related discipline

Job description

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.

Assure that manufacturing operations follow all Good Manufacturing Practices and Procedures as defined by insuring that FDA and Quality Standards are met.

• Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified.
• Design, execute and document gage R&R studies.
• Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs).
• Actively lead process improvement events leading to reduction in cost of poor quality (COPQ).
• Reduce scrap and manufacturing waste for various product lines throughout the factory.
• Quality Representative for Material Review Board (NMR) for purchased and make components.
• Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review)
• Investigate and respond to customer complaints and customer issued SCARs.
• Quality Representative for Process Validations and Transfer Validations (may require writing, reviewing, executing, analyzing and reporting on test protocols).
• Prepare quality related deliverables in a timely manner.
• Prepare and execute Engineering studies as needed.
• Responsible for CAPA root cause investigation and actions implementation.
• Implementation of SPC.
• Eliminate All Escapes to the customer. Metric goal is zero.
• Creates Controls plans
• Meet KPI Goals,Quality deliverables.
• Support Quality Culture.
• . Lean QMS initiative to reduce Muda by eliminating bureaucratic processes.
• Participate in Quality and Manufacturing Department meetings.
• Collaborate in the clarification of specifications for quality.
• Acts as a consultant for areas related to his/her expertise.
• Support Supplier management process as required .
• Participate and assist as a part of the Internal Audit team as required.
• Other duties as assigned, verbal and written.
• Follow medical device manufacturing best practices (GMP, GDP, etc.), current Nordson Medical policies and procedures, ISO 13485, 21CFR Part 820 and other applicable regulations to ensure compliance to applicable customer and regulatory requirements

Experience

- A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge.

- A minimum of 5 years related experience preferably in the medical device industry.

- Knowledge of ISO 13485:2003, GMP, FDA, QSR.

- Strong root-cause investigator and problem solver within a manufacturing environment.

- Mechanical aptitude with manufacturing experience.

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.