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
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DEKA Research and Development
Sep 05, 2025