Director, Quality

Overview

The Quality Director plays a pivotal role in leading and strengthening operational quality and quality compliance within a large-scale contract manufacturing facility. Responsible for both Product Quality and Quality Management System (QMS) compliance, this leader ensures quality operations within the manufacturing environment consistently meet customer, regulatory, and business expectations.

This individual combines strategic vision with hands-on operational quality leadership, ensuring Resonetics delivers world-class quality in a fast-paced, highly regulated medical device manufacturing environment. The role demands proven experience within manufacturing operations, deep expertise in ISO 13485 and 21 CFR Part 820, mastery of advanced quality assurance techniques, and the ability to align and elevate quality performance across multiple value streams.

Responsibilities

Operational Quality Leadership

• Own and lead all aspects of manufacturing quality performance, ensuring operational processes deliver consistent, compliant, and high-yield outcomes.
• Partner closely with Operations leadership to embed quality into daily production activities and drive problem-solving directly on the manufacturing floor.
• Implement and oversee statistical process control (SPC), process capability, and other data-driven tools to ensure process stability and continuous improvement.
• Monitor and manage critical quality metrics, taking immediate action to address gaps and prevent recurrence of issues.
• Oversee validation strategies (IQ/OQ/PQ) for manufacturing processes and equipment, ensuring robustness and compliance.
• Provide quality leadership in New Product Introduction (NPI), ensuring robust process validation, risk management, and seamless transition from development into full-scale manufacturing.

Quality Systems & Compliance

• Ensure the ISO-certified QMS is operationally effective within manufacturing sites and continuously improved to support business growth.
• Maintain full compliance with ISO 13485, 21 CFR Part 820, and other relevant standards through proactive system management and audit readiness.

Continuous Improvement & Problem Solving

• Lead root cause investigations and corrective actions for complex production challenges.
• Drive Lean and Six Sigma initiatives that enhance manufacturing efficiency while strengthening compliance and product quality.
• Share best practices across sites to ensure standardization and scalability of quality improvements.

Customer & Supplier Interface

• Serve as the primary quality leader for high-visibility customers, ensuring confidence in Resonetics' ability to deliver consistently high-quality products.
• Lead the supplier quality program, ensuring raw materials and outsourced processes meet stringent requirements to support operational excellence.

Team Leadership & Development

• Build and mentor a strong quality team embedded within the manufacturing organization.
• Provide training in advanced quality tools (Gage R&R, SPC, pFMEA, Risk Analysis, Validation, Root Cause Analysis, CAPA) to elevate operational capability.
• Foster a culture of quality culture and ownership on the production floor, engaging all levels of the workforce.

Required Qualifications

• Minimum 7 years' experience in a Medical Device Quality Management role.
• Lean and/or Six Sigma Green Belt or Black Belt
• Demonstrated background in an ISO 13485 and 21 CFR 820 quality management system.
• Strong communication skills (verbal and writing)
• BS degree in a management or engineering discipline
• Experience hosting FDA inspections and ISO audits

Preferred Qualifications

• Prior experience in a technical, regulated environment.
• Experience with finished medical device assembly and oversight of sterilization
• Experience with Quality Management Software (eQMS) and ERP systems
• Certified Quality Auditor

Physical Demands

• Light office work, approximately 25%+ travel