Quality Engineer II

Nordson Corporation•Salem, NH

About The Position

Nordson Medical is seeking an experienced Quality Engineer II to help ensure manufacturing operations comply with Good Manufacturing Practices and Procedures, FDA requirements, and applicable quality standards. The role supports quality across medical-device manufacturing and works with multidisciplinary teams, suppliers, customers, and internal departments to investigate issues, improve processes, and maintain regulatory compliance. The position contributes to root-cause analysis, corrective and preventive actions, gage R&R studies, training, process improvement, supplier quality, customer complaint handling, validations, engineering studies, statistical process control, control plans, and internal audits. The Quality Engineer also supports quality culture and lean quality-system initiatives, prepares quality deliverables, and works toward eliminating customer escapes and meeting key performance goals. Nordson Medical describes its workplace as supportive, growing, dynamic, collaborative, diverse, and inclusive, and says it invests in employees’ skill development and career advancement.

Requirements

Bachelor’s degree in engineering or a related discipline; the degree may substitute for some required years of experience and knowledge.
At least 5 years of related experience, preferably in the medical-device industry.
Knowledge of ISO 13485:2003, GMP, FDA requirements, and QSR.
Strong root-cause investigation and problem-solving skills in a manufacturing environment.
Mechanical aptitude and manufacturing experience.

Responsibilities

Ensure manufacturing operations follow Good Manufacturing Practices and Procedures and meet FDA and quality standards.
Participate in multidisciplinary teams conducting root-cause analysis, corrective and preventive action, and effectiveness checks for quality issues.
Design, execute, and document gage R&R studies.
Support training on manufacturing and quality-system documents, including SOPs, PIs, MAPs, and QAPs.
Lead process-improvement events to reduce cost of poor quality.
Reduce scrap and manufacturing waste across product lines.
Represent Quality on the Material Review Board for purchased and manufactured components.
Conduct and follow up on the SCAR process, including issuance, supplier notification, approval, and effectiveness review.
Investigate and respond to customer complaints and customer-issued SCARs.
Represent Quality for process and transfer validations, including writing, reviewing, executing, analyzing, and reporting on test protocols as needed.
Prepare quality-related deliverables in a timely manner.
Prepare and execute engineering studies as needed.
Conduct CAPA root-cause investigations and implement actions.
Implement statistical process control (SPC).
Work to eliminate customer escapes, with a stated metric goal of zero.
Create control plans.
Meet KPI goals and quality-deliverable expectations.
Support the quality culture and lean QMS initiatives to reduce waste by eliminating bureaucratic processes.
Participate in Quality and Manufacturing Department meetings.
Collaborate to clarify quality specifications.
Act as a consultant in areas of expertise.
Support supplier management as required.
Participate and assist as part of the Internal Audit team as required.
Perform other duties as assigned, verbally or in writing.
Follow medical-device manufacturing best practices, current Nordson Medical policies and procedures, ISO 13485, 21 CFR Part 820, and other applicable regulations and customer requirements.