Scientific Search · 5 hours ago
Sr Validation Quality Engineer
Racine, WI
Full-time
Hybrid
Senior LevelScientific Search is seeking a Senior Validation Quality Engineer to play a critical role in ensuring the integrity, compliance, and performance of electromechanical medical devices. This role involves leading validation activities and collaborating with various teams to drive quality in a highly regulated environment.
Human ResourcesStaffing Agency
Responsibilities
Lead product, process, test method, and equipment validation and re-validation activities
Oversee IQ/OQ/PQ activities, including computerized systems
Support new product introductions and process development initiatives
Review and approve SOPs, specifications, and validation documentation
Drive NCR, CAPA, scrap, and rework analysis for continuous improvement
Support regulatory inspections and internal/supplier audits
Partner with suppliers on quality changes and issue resolution
Qualification
Required
BS in Engineering or a Physical Science (or equivalent experience)
Deep knowledge of medical device or pharmaceutical quality systems
Strong validation, statistical analysis, and technical writing expertise
Hands-on experience with ISO 13485, FDA QSR, GMPs
Confident communicator able to lead with minimal supervision
Benefits
Competitive salary and unmatched bonuses!
Amazing benefits and time off package
Company
Scientific Search
Scientific Search is a staffing and recruiting company offering pharmaceutical, engineering, and it recruiting services.
Founded in 1983
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase