Quality Engineer II

Nordson MEDICAL (NH), Inc.; Salem (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

Nordson MEDICAL is seeking an experienced quality-focused professional to ensure manufacturing operations comply with GMP, GDP, ISO 13485, and 21 CFR Part 820. The role involves leading CAPA, SCARs, and CPQ reduction efforts across multiple product lines, plus driving validations, quality documentation, and process improvements.

You will participate in cross-functional teams, conduct gage R&R studies, support SOP trainings, and act as a quality consultant across the organization to prevent

Qualifications

• Assure manufacturing operations follow GMP/GDP and ISO 13485 standards.

Responsibilities

• Participate in multidisciplinary teams to implement root-cause analysis and CAPA actions.
• Design, execute and document gage R&R studies.
• Support training on SOPs, PIs, MAPs, and QAPs.
• Lead process improvement events to reduce COPQ and waste.
• Represent quality in Material Review Board (NMR) for components.
• Manage SCAR processes including supplier notification and effectiveness review.
• Investigate customer complaints and customer-issued SCARs.
• Lead or support validations (Process Validations, Transfer Validations).
• Prepare quality deliverables and engineering studies as needed.
• Assist in CAPA root cause investigations and corrective actions.
• Implement SPC and Lean QMS initiatives.

Skills

Root cause analysis

CAPA

Gage R&R

Process validation

SPC

SOP training

Quality systems

SCAR management

Lean QMS

Internal audits

Regulatory compliance

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

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.

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. At Nordson, we believe that anything is possible. We empower our global team of employees to engineer, manufacture, and market innovative products and systems that are essential to everyday life. These differentiated products and systems are used for precision dispensing and processing and serve a variety of end markets, including packaging, transportation, medical, and electronics. Founded in 1954, we are guided by our values of integrity, respect for people, customer passion, energy, and excellence. We care for our employees and provide them with opportunities to advance their careers and make an impact, inside and outside of work. Nordson is headquartered in Westlake, Ohio, and has direct operations in more than 35 countries to support our products and systems with application expertise and a direct global sales and service organization.