Quality Engineer II
$70,304–$102,000 year
On-siteSan Diego, California, United States
Job Summary
Monitor and disseminate customer quality alerts and process deviations while generating Customer Change Notices, validation protocols, and reports. Lead troubleshooting for quality opportunities during product launches and develop metrology equipment. Create and maintain quality/control plans, PFMEAs, and risk documentation in compliance with ISO 13485 and 21CFR820 standards. Conduct Gage R&R studies, Design of Experiments, and statistical analysis using Anova, regression, and control charts. Develop quality procedures, train personnel, approve nonconformance dispositions, and support equipment calibration and maintenance. Collaborate with customers and suppliers to ensure regulatory compliance and assist in establishing Design History Files.
Required Qualifications
- Minimum 5 years' experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience
- Demonstrated technical writing and communication skills
- Working knowledge of Statistical software and/or Minitab
- Bachelor's degree or equivalent experience
- Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required
- Experience with databases and Business Intelligence (PowerBi, Tableau, etc)
Desired Qualifications
- CQE and/or Six Sigma Green or Black belt
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics, Engineering preferred
- Strong attention to detail and satisfactory organizational skills
- Able to self-manage project task
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