Judge Direct Placement · 9 hours ago
Senior Quality Assurance Manager
Nebraska, United States
Full-time
Onsite
Senior Level, Lead/Staff
$160K/yr - $180K/yr
10+ years expThe Judge Group is seeking a Senior Quality Manager for a Fortune 500 medical device company located in Nebraska. The role involves leading QA, QC, Quality Systems & Compliance, and Quality Engineering functions while ensuring regulatory compliance and driving continuous improvement.
Staffing & Recruiting
Hiring Manager
Max Husband
Responsibilities
Lead QA, QC, Quality Systems & Compliance, and Quality Engineering functions
Develop site quality strategy and ensure regulatory compliance (FDA, ISO)
Serve as management representative for audits, inspections, and customer interfaces
Build and develop a high‑performing quality organization
Direct validation, audits, CAPA, change control, document control, and complaint systems
Partner with Manufacturing, Engineering & Supply Chain to drive continuous improvement
Champion cultural transformation and quality excellence
Qualification
Required
Bachelor's degree
10+ yrs pharma/biopharma experience and plant quality leadership
Strong knowledge of 21 CFR 820, 210/211, ISO 9001/13485
Skilled in QMS tools (SAP, TrackWise, Minitab, SAS)
Change agent with strong communication, CI mindset, and ability to influence at all levels
Ambitious, mobile, customer‑oriented, and capable of driving structural and cultural change
Preferred
advanced degree
Benefits
Relocation: YES
Company
Judge Direct Placement
JUDGE DIRECT PLACEMENT, with over 45 years of experience, is a leading provider of top management talent to companies nationwide, with a focus in the areas of Manufacturing, Engineering, Supply Chain, and Sales & Marketing.
Founded in 1970West Chester, Pennsylvania, US
1001-5000 employees
H1B Sponsorship
Judge Direct Placement has a track record of offering H1B sponsorships. Please note that this does not
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Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (35)
2024 (22)
2023 (13)
2022 (14)
2021 (19)
2020 (34)
Funding
Current Stage
Late StageCompany data provided by crunchbase