Fulfilling the promise of precision medicine through quality and innovation.
Staff Design Quality Engineer
Location
United States
Posted
1 day ago
Salary
$120K - $138K / year
Job Description
Job Requirements
- Bachelor’s degree in engineering, scientific or related field.
- Minimum 6+ years of hands-on experience, or relevant comparable background.
- Hands-on experience with ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971 IVDR.
- Technical expertise and understanding of IVD assays and data analysis tools.
- Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
- Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file.
Benefits
- Health insurance
- 401(k) matching
- Professional development opportunities
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