Sr. Director Quality Assurance

Sight Sciences; California, Menlo Park (MO, CA); Hybrid; USD 197,000 - 283,000; Full time

Job summary

Ein dynamisches Unternehmen sucht einen erfahrenen Sr. Director of Quality Assurance, der die Qualitätssysteme leitet und sicherstellt, dass alle Produkte den höchsten Standards entsprechen. In dieser Schlüsselrolle arbeiten Sie eng mit funktionsübergreifenden Teams zusammen, um eine Kultur der Qualität und Compliance zu fördern. Sie werden für die Überwachung der regulatorischen Anforderungen verantwortlich sein und sicherstellen, dass alle Prozesse effizient und effektiv sind. Diese Position bietet die Möglichkeit, einen bedeutenden Einfluss auf die Qualität und Sicherheit von Produkten zu haben und Teil eines engagierten Teams zu werden, das Innovation und Exzellenz fördert.

Qualifications

• Umfangreiche Erfahrung im Qualitätsmanagement in der Medizintechnik.
• Fähigkeit zur Führung und Entwicklung von QA-Personal.

Responsibilities

• Entwicklung und Pflege von Qualitätsrichtlinien zur Einhaltung von Vorschriften.
• Leitung interner Audits und regulatorischer Inspektionen.

Skills

Qualitätsmanagement

Regulatorische Compliance

Interne Audits

Prozessverbesserung

Teamführung

Education

Bachelor-Abschluss in Ingenieurwissenschaften oder Naturwissenschaften

Master-Abschluss in einem relevanten Bereich

Tools

Qualitätsmanagementsysteme (QMS)

Regulatorische Standards (ISO, FDA)

Job description

Overview: The Sr. Director of Quality Assurance, functioning as Head of Quality, is responsible for providing quality leadership and oversight as the global business process owner. This role involves establishing and maintaining a quality system to ensure compliant and effective processes in support of product design, development, sustaining engineering, and quality system support of the Company's products. The Sr. Director of Quality serves as the Company's Management Representative and jointly as the Person Responsible for Regulatory Compliance (PRRC) with the head of Regulatory Affairs.

Responsibilities:

1. Establish and maintain quality system policies and procedures to ensure compliance with applicable domestic and international medical device quality regulations, standards, and specifications. Keep abreast of new and revised standards and regulations, executing quality planning activities accordingly. Collaborate with functional groups to ensure effective implementation of the Quality System aligned with business objectives.
2. Build credibility and work closely with cross-functional teams to enhance the implementation of the Quality Policy. Foster a culture of quality, efficiency, and excellence, ensuring quality and compliance are integrated into daily operations and the long-term Quality strategy. Promote a Quality vision across the Company.
3. As management representative, lead the planning and execution of periodic Management Review activities. Communicate and collaborate with senior management to ensure the effectiveness of the quality management system, identify improvement areas, and promote awareness of regulatory and QMS requirements throughout the organization.
4. Perform the role of the Person Responsible for Regulatory Compliance (PRRC) as per EU Medical Device Regulations, in conjunction with the head of Regulatory Affairs.
5. Lead and promote quality and regulatory compliance through proactive internal audits. Prepare for regulatory inspections, host inspections, and maintain inspection readiness.
6. Manage processes for receiving, evaluating, and responding to customer complaints, including escalation of reportable events, trend analysis, corrective and preventive actions, and feedback to the field.
7. Oversee the corrective and preventive action process, ensuring its effectiveness and integration within the QMS.
8. Partner with R&D, Manufacturing Engineering, and Supply Chain Management to drive continuous process improvements, manage communication with contract manufacturers, and ensure consistent product quality and compliance. Ensure timely review and release of finished product batch records to meet sales demands.
9. Oversee internal QMS training, develop training materials for commercial partners and sales teams on quality and regulatory compliance.
10. Lead the recruitment, development, training, and management of QA personnel. Oversee staff performance aligned with organizational goals.
11. Manage the QA department budget and resources, providing inputs for the annual budget, periodic re-forecasts, and overseeing expenditures to meet financial objectives.
12. Perform all other duties as assigned, in accordance with company policies, procedures, and applicable laws and regulations.

#LI-Hybrid

For California, the base salary range is $197,700 - $282,500 annually, with highly competitive, performance-based compensation programs.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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