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Director of quality • manchester nh
Director of Manufacturing Quality
DEKAManchester, NH, United States- serp_jobs.job_card.promoted
Director, Manufacturing Quality - medical device manufacturing quality
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DEKAManchester, NH, United States- serp_jobs.job_card.full_time
We are looking for an exceptional Director of Manufacturing Quality to lead our quality organization and drive excellence across all aspects of our medical device manufacturing operations. This is a unique opportunity for a hands-on leader who thrives in a fast-paced, innovative manufacturing and NPI environment.
How you will make an impact as a Director of Manufacturing Quality :
The successful candidate will be responsible for ensuring production processes are well controlled and compliant, driving continuous improvement and consistent product quality.
Quality Leadership & Strategy :
- Provide strategic leadership and continuous improvement of a manufacturing-focused Quality Management System (QMS), ensuring compliance with FDA QSR GMP's and ensuring that all products, processes, and practices meet regulatory and high-quality standards
- Lead the Management Review process to evaluate QMS performance, and ensure alignment with business goals
- Facilitate risk-based, cross-functional decision-making and embed quality principles across all organizational levels
- Foster a culture of quality excellence, accountability, and continuous improvement
- Build, scale, and mentor a high-performing Quality Engineering and Quality Assurance team aligned with organizational growth and operational goals
- Establish QMS performance metrics and dashboards to monitor trends, support data-driven decisions, and enhance organizational visibility
- Administer and optimize core quality systems including, but not limited to : Corrective and Preventive Action (CAPA), Change Control, Document Control, Training, Complaint Handling, and Audits
- Prepare for and host regulatory audits from FDA, Notified Bodies, and strategic partners
Product Quality
Skills needed to be successful :
Deep knowledge of FDA QSR (21 CFR Part 820) Good Manufacturing Practices
People-focused leader with proven ability to build and develop high-performing teams
Preferred Qualifications :