Site Quality Engineering Manager (Site Quality Management Representative) – Medical Device Manufacturing
Location: Dayton, OH this is an On-Site position
Are you ready to take the next step in your career with a world-class medical device strategic manufacturing partner?
We're seeking a Quality Manager to serve as the Site Quality Management Representative for a facility experiencing high growth.
This is a high-impact leadership role in an expanding operation, offering the opportunity to drive quality excellence, build and lead a growing team, and work at the forefront of medical device manufacturing.
🔍 What We’re Looking For:
✅ 8+ years in Quality Engineering / Quality Assurance
✅ Medical Device m anufacturing experience preferred; Aerospace/Defense also acceptable
✅ Management experience OR strong leadership potential considered
✅ ISO 13485 & 21 CFR 820 compliance expertise + Audit experience
✅ BS in Engineering or related discipline strongly preferred
✅ Experience in Process Validation , On-Time Delivery, Lot Acceptance Rates, and Systematic Quality Improvements
✅ Hands-on leader who can engage, motivate, and inspire the workforce
Key Responsibilities and Objectives:
🔹 Serve as the primary site Quality & Compliance representative
🔹 Lead Quality personnel hiring, training, and development
🔹 Oversee the site Quality department budget
🔹 Act as site Management Representative for audits and compliance
🔹 Manage the interface between customer supplier quality organizations
🔹 Support manufacturing process transitions & sustainment
🔹 Implement corporate quality system documents at the site level
🔹 Utilize Lean Six Sigma, Process Validations, and Risk Management techniques
🔹 Lead external audits and regulatory compliance efforts
🔹 Drive continuous improvement and process optimization initiatives
Why Join this Organization?
Be a key leader in a fast-growing, high-tech manufacturing environment
Shape the future of a facility set for rapid expansion
Make an impact in life-changing medical device manufacturing
Opportunity for long-term career growth in a world-class organization
If you're a driven, hands-on leader with a passion for quality and innovation, please apply/DM.
#QualityManager #MedicalDevice #Manufacturing #ISO13485 #LeanSixSigma #QualityLeadership #Hiring
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