Senior Quality Assurance Engineer I
Merit Medical
Senior Quality Assurance Engineer supporting medical device product lines with failure investigation, nonconformance disposition, risk analysis, inspection planning, and quality systems optimization. Reports to quality leadership and may mentor junior engineers and technicians.
Responsibilities
- Investigate product failures and determine disposition of nonconforming materials
- Develop, review, and update risk analysis documentation and quality inspection plans
- Collect, trend, and present quality metrics and performance data
- Review and generate validation protocols, verification procedures, and Engineering Change Notifications
- Monitor supplier performance through audits, data collection, and corrective action follow-up
Requirements
- Bachelor's degree in engineering or related field plus six years quality engineering experience
- Proficiency with 21 CFR 820, ISO 13485, ISO 14791, and medical device regulations
- Knowledge of statistical methods, lean manufacturing, and Six Sigma methodologies
- Strong communication, teamwork, and conflict resolution capabilities
- Computer literacy with spreadsheets, databases, and engineering software
- Medical device industry experience preferred
Vacancy posted 22 days ago
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