Director, Quality

Reporting directly to the Chief Supply Chain Officer, the Director of Quality will serve as Element's senior Quality leader, independent Quality authority, and Management Representative for the company's ISO 13485 Quality Management System. This role will have responsibility for Quality Systems, Quality Engineering, Supplier Quality, Quality Control and incoming inspection, Document Control, audit and inspection readiness, and product and process quality.

The Director will build upon Element's existing quality system foundation and partner closely with Product Development, Manufacturing, Supply Chain, Service, Regulatory Affairs, Clinical, and other functions to ensure that products and processes meet applicable quality requirements throughout the product lifecycle.

Essential Functions and Responsibilities

• Lead Element's Quality function and QMS, establishing Quality strategy, policies, objectives, metrics, and priorities and ensuring continued compliance with applicable quality system regulations, standards, company policies, and procedures
• Serve as Management Representative for the ISO 13485 QMS, ensuring required QMS processes are established and maintained, reporting QMS performance and improvement needs to executive management, and promoting awareness of applicable quality and regulatory requirements throughout the organization
• Serve as the company's senior Quality authority, providing independent judgment and escalation on significant product, process, supplier, and quality system risks and leading Management Review, CAPA, nonconformance, complaint, change control, document control, and continuous improvement processes
• Lead product and process quality throughout the lifecycle, including design controls, risk management, verification and validation, new product development, design transfer, manufacturing readiness, sustaining changes, incoming/in-process/final quality controls, and product release
• Own Supplier Quality, including supplier qualification and monitoring, risk classification, quality agreements, supplier audits, corrective actions, and escalation of significant supplier related risks
• Lead organizational inspection and audit readiness, including FDA inspections, ISO certification and surveillance audits, notified body QMS audits, customer audits, and other Quality-related assessments, and ensure timely and effective resolution of findings
• Partner with Regulatory Affairs on regulated product lifecycle and post-market activities, with Quality responsible for investigation, root cause analysis, quality risk assessment, containment, and corrective action, and Regulatory Affairs responsible for regulatory impact assessments, reporting, notifications, and market authorization implications
• Build and develop a high performing Quality organization, establishing clear accountability, decision rights, scalable processes, and a culture of proactive risk management, constructive challenge, continuous improvement, and cross-functional partnership

Education and Experience

• Bachelor's degree in engineering, life sciences, chemistry, or a related technical discipline; advanced degree preferred
• Typically 15+ years of progressively responsible Quality experience within medical devices, IVDs, life science tools, or similarly regulated products, including significant leadership responsibility
• Demonstrated experience leading and scaling Quality organizations and ISO 13485 Quality Management Systems, including experience serving as or working closely with a Management Representative
• Deep working knowledge of ISO 13485, FDA quality system requirements, ISO 14971, design controls, CAPA, complaint handling, change control, supplier quality, validation, and auditing principles
• Demonstrated experience leading regulatory inspections, ISO/notified body audits, and other external Quality audits, including management of findings and corrective actions
• Strong experience supporting product development, design transfer, manufacturing, and commercial product lifecycle processes; experience with complex instrumentation, IVD, NGS, software enabled products, or SaMD preferred
• Strong risk-based judgment, executive communication skills, and demonstrated ability to influence technical and business leaders while maintaining appropriate Quality independence and authority
• Self-directed, pragmatic, collaborative, and comfortable operating in a fast-paced environment with evolving priorities; demonstrated commitment to developing people and organizational capability
• ASQ certifications such as CQE, CQA, or CMQ/OE are preferred

Physical Requirements

• Must be able to lift up to 15 pounds.

Location

San Diego (on-site)

Travel

Willingness to travel up to approximately 10% of the time