Job Description

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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