Quality Engineer II

Nordson; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

Nordson MEDICAL is seeking an experienced quality-focused professional to join our team in a manufacturing quality role. You will help ensure GMP and FDA/Quality standards are met, participate in multidisciplinary teams for root-cause analysis and CAPA, and design, execute, and document gage R&R studies.

You will also support training on SOPs/PI/MAP/QAP documents, lead process-improvement events to reduce COPQ, and drive reductions in scrap and waste across multiple product lines.

Qualifications

• Ensure manufacturing operations follow GMP and FDA/Quality standards.
• Participate in multidisciplinary teams for root-cause analysis and CAPA.
• Design, execute and document gage R&R studies.
• Support training on Manufacturing and Quality System documents.
• Lead process improvement events to reduce 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 and effectiveness review).
• Investigate and respond to customer complaints and customer issued SCARs.
• Quality Representative for Process Validations and Transfer Validations (may write, review, execute, analyze and report on test protocols).
• Prepare quality related deliverables in a timely manner.
• Prepare and execute Engineering studies as needed.
• CAPA root cause investigations 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

Responsibilities

• Ensure GMP and FDA/Quality standards compliance in manufacturing.
• Lead CAPA and root cause investigations.
• Perform gage R&R studies and document results.
• Support training on SOPs, PIs, MAPs, QAPs.
• Lead cost reduction of COPQ via process improvements.
• Reduce scrap and waste across product lines.
• Serve as Quality Rep for NMR and SCAR processes.
• Coordinate internal and supplier audits.
• Respond to customer complaints and SCARs.
• Implement SPC and quality metrics.

Skills

GMP knowledge

CAPA

Root cause analysis

SCAR process

SPC

Quality systems

Documentation

Tools

Gage R&R

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

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.