Quality Assurance Manager

Site Quality Manager (Site Quality Management Representative) - Medical Device Manufacturing** Columbus, OH This is an On-Site positionRelocation support is available (lump sum)Are you ready to take the next step in your career with a world-class medical device strategic manufacturing partner? Were 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 months.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.🔍 What We're Looking *✅ 8+ years in Quality Engineering or Quality Assurance✅ Medical Device Manufacturing experience preferred; Aerospace/Defense also considered✅ Management experience OR a strong leadership track record✅ ISO 13485 & 21 CFR 820 compliance expertise + Audit experience✅ BS in Engineering or related discipline strongly preferred✅ Experience in CAPA, Complaint Handling, On-Time Delivery, Lot Acceptance Rates, and Systematic Quality Improvements✅ Hands-on leader who can engage, motivate, and inspire the workforce💼 Key Responsibilities and ****🔹 Serve as the primary site Quality & Regulatory 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 initiativesWhy 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 organizationIf youre a driven, hands-on leader with a passion for quality and innovation, please apply or reach out.#QualityManager #MedicalDevice #Manufacturing #ISO13485 #LeanSixSigma #QualityLeadership #Hiring

Created: 2025-03-02