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.
