Senior Director, Quality Operations EU

Das ist der Job

Changing lives.

Darum lohnt es sich

Key Responsibilities Leadership & Strategy — Provide leadership and direction to site Quality Assurance teams, including direct oversight of Site Quality leaders. People Development — Develop and mentor Quality leaders and team members across sites, building strong succession pipelines. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Act as the primary Quality liaison and escalation point for the Le Locle, St. Aubin, and RW sites. Translate global Quality strategy into effective site-level execution aligned with Integra policies and business objectives.

Serve as a trusted advisor to site leadership on Quality, risk management, and compliance matters. Quality Systems Oversight — Ensure robust and effective implementation of Quality Management System (QMS) processes, including CAPA, nonconformance management, complaints, change control, document control, and risk management.

Drive harmonization and consistency of Quality processes across sites while accounting for local regulatory and operational needs. Oversee management review processes and ensure timely escalation of quality risks and performance trends.

Regulatory & Inspection Readiness — Ensure ongoing compliance with applicable regulations and standards, including FDA QSR, ISO 13485, EU MDR, and other global regulatory requirements. Lead site preparation for regulatory authority inspections, notified body audits, and customer audits; serve as a key inspection leader as needed.

Review, approve, and ensure timely and effective responses to inspection observations, including FDA 483s, audit findings, and warning letters. Operational Quality Support — Partner with Operations and Manufacturing leadership to support production while maintaining compliance and quality standards.

Provide Quality leadership for deviations, investigations, product impact assessments, and product release decisions. Ensure effective change management and risk assessments for process, equipment, and product changes. CAPA & Continuous Improvement — Ensure effective root cause analysis, CAPA development, and execution with measurable outcomes.

Utilize quality metrics, trend analysis, and data-driven insights to proactively identify and mitigate risks. Lead and support continuous improvement initiatives to enhance quality, compliance, and efficiency. Foster a culture of accountability, transparency, and continuous learning. Ensure appropriate training and competency for Quality personnel.

Required Qualifications Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline; advanced degree preferred. Minimum of 10–12 years of progressive Quality experience in the medical device or regulated healthcare industry. Demonstrated experience leading Quality organizations in a manufacturing environment.

Strong working knowledge of global Quality and regulatory requirements, including FDA QSR, ISO 13485, and EU MDR. Proven experience leading regulatory inspections and audits. Experience managing across multiple sites or complex organizations. Fluent in English and French.

Preferred Qualifications Prior experience in a Director‑level or equivalent senior Quality leadership role. Experience serving as a span‑breaker or matrix leader across geographically dispersed sites. Strong change leadership and continuous improvement mindset (Lean, Six Sigma, or similar preferred).

Experience working within a global or multinational organization. #J-18808-Ljbffr