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.
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
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