Engineer I, Quality

Position Summary:

The Manufacturing Quality Engineer I is an entry/developing role that supports day-to-day manufacturing quality assurance activities in a regulated medical device manufacturing environment. The role assists with NCMR coordination, containment documentation, routine investigation support, CAPA task follow-up, complaint evidence gathering, and continuous improvement actions under the direction of more experienced Quality Engineers.

Essential Duties & Responsibilities:

• Review new NCMRs for completeness of item, lot/serial, quantity, defect description, source, containment status, attachments, photos, and impacted locations.


• Support containment verification, product segregation, evidence collection, DHR/traveler review, inspection/test data review, and related NCMR history gathering.


• Draft routine NCMR investigation summaries, factual complaint support inputs, and recommended next steps for QE II/QE III review.


• Maintain timely updates in SharePoint, Power Automate, Oracle/ERP, or site trackers and escalate aging records or missing information.


• Support CAPA administration by collecting objective evidence, updating task status, preparing implementation records, and following up on assigned actions.


• Recognize and escalate potential CAPA signals, recurrence, complaint severity, field-risk concerns, systemic process-control concerns, or unclear disposition rationale.


• Provide daily manufacturing-floor support for quality questions, line holds, sort/rework verification, inspection criteria clarification, and procedural adherence as assigned.


• Participate in defect-reduction, 5S, visual management, Kaizen, PDCA/A3, and quality-health improvement activities.


• Follow GDP, data integrity, document-control, training, and procedural requirements to maintain audit-ready records.

Knowledge, Skills & Qualifications:

• Basic understanding of GDP, NCMR workflow, containment, DHR/traveler records, inspection/test data, complaint support, CAPA task support, and regulated manufacturing expectations.


• Developing skill in 5-Why, fishbone, Pareto, check sheets, basic process mapping, 5S, PDCA/A3, Kaizen participation, and basic risk concepts.


• Working knowledge of Excel, SharePoint, Oracle/ERP basics, and Power Automate workflow awareness preferred.


• Ability to communicate clearly, ask for help early, follow through on assignments, and maintain accurate documentation.

Education and Experience:

• Must be at least 18 years of age.


• Bachelor’s degree from an accredited college or university in Engineering, Science, Quality, Technology, or a related discipline; or equivalent combination of education and relevant manufacturing/quality experience.


• 0-2 years of quality, manufacturing, engineering, inspection, or regulated-industry experience preferred.


• Medical device, ISO 13485, FDA QMSR/cGMP, Oracle/ERP, SharePoint, or Power Automate exposure is helpful.


• Six Sigma and Lean awareness recommended.

Physical Requirements and Work Environment:

• This role requires both manufacturing and office environment.


• While working in the manufacturing environment, high-noise areas, radiological hazards, lasers, and/or biological hazards may be encountered.


• Lift up to 40 lbs unassisted.


• Typically requires travel less than 5% of the time.