Quality Engineer II

Nordson Corporation; New Hampshire; On-site; USD 70,000 - 95,000; Full time

Job summary

Nordson Medical is seeking a quality-focused professional to join our team in the United States. You will help ensure that manufacturing operations comply with GMP, GDP, ISO 13485, and 21 CFR Part 820 while supporting root-cause analysis, CAPA, and quality improvements.

You will participate in cross-functional teams, lead process improvement efforts, and drive reduction of scrap and COPQ. The role involves documenting tests, validating processes, and ensuring timely quality deliverables across

Responsibilities

• Participate in multidisciplinary teams to implement root-cause analysis and CAPA.
• Design, execute and document gage R&R studies.
• Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs).
• Lead process improvement events to reduce cost of poor quality (COPQ).
• Reduce scrap and manufacturing waste across product lines.
• Quality Representative for Material Review Board (NMR) for components.
• Conduct and follow up of SCAR process (SCAR issuance, supplier notification, SCAR approval).
• Investigate and respond to customer complaints and SCARs.
• Quality Representative for Process Validations and Transfer Validations.
• Prepare quality related deliverables and engineering studies.
• Responsible for CAPA root cause investigation and actions implementation.
• Implementation of SPC.
• Eliminate all escapes to the customer.
• Creates Controls plans and meet KPI goals.

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

Interested?

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 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.