Description
Job Responsibilities* Develops and implements quality system documentation (operating procedures, work instructions, specifications, and so on)
* Participates in cross functional project teams to support new product development and quality improvements
* Performs Risk Assessments (e.g. FMEA, FTA, Risk Analysis)
* Develops and implements acceptance activities (tests, test equipment, sampling, and inspection)
* Installs, operates, troubleshoots and maintains test equipment
* Performs statistical analysis/hypothesis testing
* Implements and monitors Statistical Process Control (SPC)
* Develops, implements, and monitors processes and procedures for environmental controls
* Develops and executes IQ, OQ, PQ protocols and reports
* Develops and implements corrective actions and preventive actions
* Determines outcome of non-conforming materials and devices
* Conducts internal and external quality audits
Job Qualifications
* Bachelors degree in science, engineering, or a related field
* Ten years minimum experience in quality process improvement experience with class II/III medical devices
* Extensive experience with ISO 13485:2012, ISO 14971:2012, 21 CFR 820, SOR 98/282, and MDD 93/42
* Computer skills (MS Word, Excel, PowerPoint, etc…)
* Extensive knowledge and experience in statistical analysis
* Good English skills (written and spoken)
* Strong teamwork skills
* Result oriented
* American Society for Quality certifications (CQT, QAT, CQA, CQPA, CCT) preferred
* Catheter/Stent experience
Salary:
Quality Engineer: $70,000 - $80,000
Senior Quality Engineer: $95,000 - $110,000
To find out more about Real please visit www.realstaffing.com