Senior Director, Global Quality Operations (EU)

integralife; Freiburg; Vor Ort; CHF 250.000 - 320.000; Vollzeit

Zusammenfassung

Integra LifeSciences seeks a Sr Director of Quality Assurance to lead Quality operations across Le Locle, St. Aubin, and RW sites. You will ensure global QMS compliance, regulatory readiness, and continuous improvement while partnering with site leadership and corporate Quality.

Responsibilities include directing CAPA programs, change control, risk management, and product release decisions, with a focus on patient safety and business continuity.

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Minimum 10–12 years of progressive Quality experience in medical devices or regulated healthcare.
• Fluent in English and French.
• Experience leading Quality organizations across multiple sites.

Aufgaben

• Provide leadership to site Quality Assurance teams across Le Locle, St. Aubin, and RW sites.
• Oversee Quality Management System processes including CAPA, nonconformance, complaints, change control, document control, and risk management.
• Lead regulatory inspections, audits, and responses to observations (e.g., FDA 483s).
• Partner with Operations to support production while maintaining quality standards.
• Drive CAPA and continuous improvement with measurable outcomes.
• Mentor Quality leaders and build succession pipelines across sites.

Kenntnisse

Leadership

Quality management

French

English

Regulatory knowledge

Ausbildung

Bachelor’s degree in Engineering or Life Sciences

Master’s degree preferred

Jobbeschreibung

Integra LifeSciences seeks a Sr Director of Quality Assurance to lead Quality operations across Le Locle, St. Aubin, and RW sites. You will ensure global QMS compliance, regulatory readiness, and continuous improvement while partnering with site leadership and corporate Quality.

Responsibilities include directing CAPA programs, change control, risk management, and product release decisions, with a focus on patient safety and business continuity.