Director, Quality Assurance in Tustin, California - #73369 | VanderHouwen

Description

Job Id: 73369

Director, Quality Assurance
Our client is seeking a Director, Quality Assurance to build and lead the quality management system for an emerging medical device business developing next-generation cardiac ablation technology. The company has completed early clinical validation and is now preparing for regulatory approvals and commercial launch. This is a highly visible leadership role for an experienced quality professional who wants to shape a quality organization from the ground up.

This role is on-site in Tustin, California with occasional domestic and international travel.

Director, Quality Assurance Responsibilities

• Establish, lead, and continuously improve the company’s Quality Management System, including the Quality Manual, critical SOPs, and the processes needed for regulatory readiness and commercial launch.
• Serve as Management Representative, overseeing QMS documentation, effectiveness reporting, and improvement planning while promoting quality and regulatory awareness across the organization.
• Act as a Person Responsible for Regulatory Compliance, ensuring product conformity prior to commercialization and confirming post-market surveillance obligations are met.
• Lead quality system efforts supporting ISO 13485 certification, EU MDR compliance, FDA readiness, and state regulatory requirements.
• Manage quality-related interactions with Notified Bodies, regulatory agencies, critical suppliers, and contract development organizations.
• Lead and support internal, supplier, Notified Body, regulatory, and customer audits, including preparation, responses, and follow-up actions.
• Provide Quality Engineering leadership throughout product and process development to ensure compliance, manufacturability, reliability, and conformance to requirements.
• Oversee design controls, Design History Files, and product risk management files, keeping them complete, inspection-ready, and aligned with clinical use, complaints, and post-market information.
• Support verification and validation activities, including sterilization, biocompatibility, package integrity, shelf life, software validation, and electrical safety.
• Manage critical suppliers through qualification, audits, quality agreements, and corrective actions.
• Lead failure investigations, nonconformance evaluations, root-cause analysis, CAPA, and effectiveness checks.
• Monitor evolving regulations, standards, and guidance applicable to Class III cardiac devices, and apply statistical methods and continuous improvement practices.

Director, Quality Assurance Qualifications

• 10+ years of progressive experience in Quality Assurance, Quality Engineering, or Systems Engineering within the cardiac medical device industry, preferably in cardiac ablation.
• Demonstrated lead-role experience implementing a QMS and supporting successful audits leading to ISO 13485 certification.
• Deep working knowledge of ISO 13485, EU MDR 2017/745, ISO 14971, FDA Quality System Regulation, and applicable FDA guidance.
• Strong background in design controls, risk management, process qualification, validation (IQ/OQ/PQ), CAPA, NCRs, complaints, and GMP.
• Regulatory experience with PMA, 510(k), CE Mark, and Class III device processes, including direct interaction with Notified Bodies, FDA, and state agencies.
• Experience managing supplier quality and working with contract manufacturers and contract development organizations.
• Working knowledge of biocompatibility, sterilization, packaging, shelf life, reliability, software validation, and electrical safety standards.
• Experience supporting clinical trial monitoring, audits, or inspections is preferred.
• Strategic leader who influences cross-functional teams and senior stakeholders, communicates clearly with executives and regulators, and manages multiple complex priorities with strong attention to detail.
• Bachelor’s degree in health, life sciences, engineering, biomedical engineering, or a related field. Advanced degree preferred.

Salary: $150K-$220K/year + Bonus. (DOE)

Benefits
Benefits are available to eligible full-time employees and include coverage for medical, dental, vision, life insurance, short and long term disability, and matching 401k.

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