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 manufacturing 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.