Director of Manufacturing Quality

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 Oversee and approve key documentation related to product quality, including DMRs, DHRs, validation protocols, deviations, and nonconforming materials Apply risk management principles to ensure deviations, nonconforming materials, and quality events are appropriately assessed, reviewed, and dispositioned to ensure product safety and compliance Implement and maintain design controls to support manufacturing scale-up and commercial distribution Partner cross-functionally with R&D, Operations, Regulatory, and Commercial Manufacturing teams to align quality systems with product lifecycle needs Ensure effective root cause analysis and timely implementation of corrective actions Manage quality across the supply chain, with a focus on oversight of component and subassembly suppliers Skills needed to be successful : Bachelor's degree in Engineering, Life Sciences, or related field Minimum 10+ years of progressive quality management direct experience in medical device manufacturing, including responsibility for the quality of shipping product 5+ years in senior quality leadership roles (Director / VP level) Proven experience with FDA-regulated medical device environments Technical Expertise Deep knowledge of FDA QSR (21 CFR Part 820) Good Manufacturing Practices Demonstrated experience with regulatory audits and inspections Strong background in CAPA systems, risk management (ISO 14971), and design controls Experience with electronic QMS implementation and management Supplier quality management Data collection and statistical techniques for process control Planning, executing and maintaining process validations Assembly line implementations, qualifications, upgrades, and maintenance Leadership Attributes People-focused leader with proven ability to build and develop high-performing teams Problem-solving mindset with analytical thinking and root cause analysis skills Adaptable and resilient - comfortable operating in fast-paced, changing environments Hands-on approach – being present on the assembly lines and seeking “ground level” perspectives and data Excellent communication skills with ability to influence at all organizational levels Strategic thinking combined with tactical execution capabilities Preferred Qualifications : ASQ Certified Quality Engineer (CQE) or similar professional certification Experience with Class II / III medical devices Experience with design controls and product development quality Experience with quality metrics and KPI development About DEKA : One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world.
• It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
• Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing.
• Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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