Senior Quality Engineer - Medical Device NPI & CAPA Lead
Sterling Engineering
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Job summary
Sterling Engineering in Libertyville, IL is seeking an experienced Senior Quality Engineer to support a medical device manufacturing operation. This hands-on role requires quick ramp-up and strong NPI, risk analysis, PFMEA/FMEA, CAPA, and inspection planning expertise.
You will partner with manufacturing, engineering, calibration, and cross-functional teams, interacting with customers as needed and driving continuous improvement to meet quality and regulatory requirements.
Qualifications
- Bachelor’s degree in Engineering or related field is required.
- 6+ years of quality engineering experience in a medical device environment.
- Strong experience with NPI, risk analysis, FMEA/PFMEA and CAPA.
Responsibilities
- Support NPI projects from a quality engineering perspective.
- Lead risk analysis, FMEA/PFMEA and other quality planning activities.
- Develop and implement inspection plans and support activities.
- Lead CAPA investigations and root-cause analysis.
- Collaborate with manufacturing and engineering to drive process improvements.
- Ensure compliance with ISO 13485 and medical device quality systems.
- Interact with customers on quality-related issues as needed.
- Maintain quality data sheets and documentation.
Skills
Education
Tools
Job description
Sterling Engineering in Libertyville, IL is seeking an experienced Senior Quality Engineer to support a medical device manufacturing operation. This hands-on role requires quick ramp-up and strong NPI, risk analysis, PFMEA/FMEA, CAPA, and inspection planning expertise.
You will partner with manufacturing, engineering, calibration, and cross-functional teams, interacting with customers as needed and driving continuous improvement to meet quality and regulatory requirements.
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