Quality Engineer II (Electronics)

External

Nordson · US

Full-timeOn-siteToday

ComplianceCross-functional CollaborationData AnalysisDocumentationRisk ManagementTechnical Writing

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About the role

We are seeking a Quality Engineer II - Electronics to support and enhance our Quality Management System (QMS) while ensuring the quality and compliance of electronic components and medical devices across their lifecycle-from design and manufacturing to post-market performance. In this role, you will lead quality initiatives, drive problem-solving activities, and collaborate cross-functionally to ensure products meet regulatory and customer requirements. This is a high-impact position requiring strong analytical skills, engineering judgment, and the ability to manage multiple priorities in a fast-paced, regulated environment.

Responsibilities

Lead investigations for complaints, nonconformances, and CAPAs, including root cause analysis and effectiveness checks

Drive CAPA activities to timely and effective closure

Partner with Manufacturing, R&D, Engineering, Regulatory, and Supply Chain teams to support product quality

Support and execute validation activities (IQ/OQ/PQ), test methods, and equipment qualifications

Develop and maintain risk management documentation (FMEAs, risk assessments)

Analyze data trends to identify improvement opportunities and reduce variability

Support supplier quality initiatives, including monitoring, audits, and corrective actions

Review and approve engineering changes, validation documents, and quality records

Mentor junior engineers and provide guidance to QA technicians

Contribute to continuous improvement and cost/waste reduction initiatives.

What You Bring

Bachelor's degree in Engineering or related technical field

4-6 years of experience in a quality role (medical device or regulated industry preferred)

Strong experience in CAPA, nonconformance management, and root cause analysis

Hands-on validation experience (IQ/OQ/PQ, test method validation)

Knowledge of ISO 13485, ISO 14971, FDA QMSR, MDSAP, and EU MDR

Experience with supplier quality and risk management

Proficiency in data analysis and statistical tools (Minitab preferred)

Strong technical writing, communication, and project management skills

Ability to work independently and manage competing priorities

Preferred

ASQ Certification (CQE, CQA, SSBB, etc.)

Lead Auditor experience

Experience supporting audits and regulatory inspections

Why Join Us

Work on meaningful medical device products that impact patient care

Collaborate with cross-functional teams in a growth-focused environment

Opportunity to lead initiatives and drive measurable quality improvements

Additional Information

Work environment: Office-based with cross-functional collaboration

Travel: Minimal (~10%)

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

Quality Engineer II (Electronics)

About the role

Responsibilities

Additional Information

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Company Intel

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