Senior Director Quality Assurance

Our medical device client is hiring a Sr. Director, Design and Supplier Quality Assurance to join their team! Hybrid schedule 1-2 days onsite in the Hudson MA area.

This role provides global leadership for NPI design controls, design transfer, and the validation, maintenance, and continuous improvement of both CMO production and supplied materials. This role holds direct accountability for Design Quality (DQA), Supplier Quality (SQA), Test Method Validation (TMV), Computer System/Software (non-product) Validation (CSV), labeling and sterilization compliance, and periodic/ad-hoc risk reviews.

Qualifications:

• Bachelor’s Degree in engineering or related field
• 15 years of related experience in the medical device industry with at least 12 years in a management/leadership role in quality / regulatory / compliance.
• Understanding of relevant global/regional medical device regulations and standards with particular emphasis on MDSAP, MDR, and APAC regions
• Computer skills: MS office applications-ServiceMax and Oracle is a plus

Key Responsibilities:

Leadership & Culture

• Lead through company values and reinforce a strong, global Quality Culture.
• Build a culture of accountability, action, and on-time delivery.
• Set SMART goals, provide coaching and feedback, and mentor team members for career growth.
• Preserve effective relationships even in dynamic or challenging circumstances.
• Demonstrate hands-on leadership and a commitment to continuous improvement.

Strategic Quality & Compliance Ownership

• Establish and communicate a zero-defects vision aligned with company strategy and objectives.
• Maintain global accountability for Design & Supplier Quality performance, sterilization/labeling compliance, and successful design transfer.
• Share accountability with Quality Systems (QS) and Regulatory Affairs (RA) for maintaining a compliant, effective global Quality Management System (QMS).
• Support integration of new acquisitions into the global QMS.

Cross-Functional Collaboration

• Partner across functions to drive operational excellence, create synergies, and achieve business goals.
• Collaborate with Procurement to define supplier performance metrics and implement corrective actions.
• Work closely with Field Service to understand customer issues and support product/process improvements.
• Participate in Management Review preparation and leadership.

Process Excellence & Digital Transformation

• Identify market trends and emerging customer needs to inform quality strategy.
• Lead risk-based planning and contingency development to support AOP/LT goals.
• Implement external and internal best practices to optimize processes.
• Champion digital and AI/ML-enabled solutions to automate manual processes, accelerate quality data analysis, enhance trend detection, and uncover deeper correlations.

Technical Quality Responsibilities

• Lead and support CAPA activities end-to-end.
• Maintain expertise in statistical analysis, sampling plan development, and advanced problem-solving tools.
• Establish supplier process controls aligned with a zero-defects philosophy (e.g., FMEA, control plans, verification/validation, risk engineering).
• Define supplier classifications and control levels based on risk.
• Support Quality and Sustaining Engineering with project assignments and technical deliverables.