Quality Engineer I
$75,841–$101,121 year
On-siteVirginia Beach, Virginia, United States
Job Summary
Lead quality engineering for product development and sustaining engineering, serving as the representative across the entire lifecycle from concept development to sustaining engineering. Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 by managing design controls, verification and validation, risk management activities, and design reviews. Support and approve NCRs, CAPAs, deviations, and change controls while developing inspection strategies and control plans. Partner with Procurement, Manufacturing, and R&D to drive supplier quality and continuous improvement initiatives, monitoring quality metrics and reporting findings to management.
Required Qualifications
- Bachelor's Degree – Engineering
- TWO (2) Years – Engineering experience or similar regulated industry (with a Bachelor's)
- Zero (0) years with a Master's Degree
- Excellent verbal and written communication skills
- Proficient in MS Office: PowerPoint, Excel, Word, Outlook, Microsoft Suite
- Able to prioritize multiple, competing priorities and manage time/workload
- Able to perform tasks thoroughly and with care
- Ability to mentor junior staff and lead teams
- Ability to be collaborative and work as part of a team
- Must be able to lift 50 lbs
Desired Qualifications
- Master's Degree or PhD – Engineering
- Experience in medical devices or similar regulated industry
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