Demo

Quality Assurance Manager

Agile Search Inc.
Columbus, OH Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 3/29/2025

Site Quality Manager (Site Quality Management Representative) – Medical Device Manufacturing


Location: Columbus, OH This is an On-Site position; relocation support available (lump sum)


Are you ready to take the next step in your career with a world-class medical device strategic manufacturing partner? We are seeking a Quality Manager to serve as the Site Quality Management Representative for a facility that is set to double in size within the next 12 monthsβ€”and there is continued growth in the forecast.


This is a high-impact leadership role in a rapidly expanding operation, offering the opportunity to drive quality excellence, build and lead a growing team, and work at the forefront of medical device manufacturing.


πŸ” What We’re Looking For:

βœ… 8 years in Quality Engineering or Quality Assurance

βœ… Medical Device Manufacturing experience preferred; Aerospace/Defense also considered

βœ… Management experience OR a strong leadership track record

βœ… ISO 13485 & 21 CFR 820 compliance expertise Audit experience

βœ… BS in Engineering or related discipline strongly preferred

βœ… Experience in CAPA, Complaint Handling, On-Time Delivery, Lot Acceptance Rates, and Systematic Quality Improvements

βœ… Hands-on leader who can engage, motivate, and inspire the workforce


πŸ’Ό Key Responsibilities and Objectives:

πŸ”Ή Serve as the primary site Quality & Regulatory representative

πŸ”Ή Lead Quality personnel hiring, training, and development

πŸ”Ή Oversee the site Quality department budget

πŸ”Ή Act as site Management Representative for audits and compliance

πŸ”Ή Manage the interface between customer supplier quality organizations

πŸ”Ή Support manufacturing process transitions & sustainment

πŸ”Ή Implement corporate quality system documents at the site level

πŸ”Ή Utilize Lean Six Sigma, Process Validations, and Risk Management techniques

πŸ”Ή Lead external audits and regulatory compliance efforts

πŸ”Ή 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 or reach out.


#QualityManager #MedicalDevice #Manufacturing #ISO13485 #LeanSixSigma #QualityLeadership #Hiring

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