Site Quality Engineering Manager (Dayton)

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.

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