Senior Director, Quality Operations EU

Job description

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Sr Director, Quality Assurance provides strategic and operational leadership for Quality Assurance across multiple manufacturing sites within the CSS organization at Integra LifeSciences . Serving as a critical span ‑ breaker , this role oversees Quality operations for the Le Locle , St. Aubin, and RW sites, ensuring consistent execution of global Quality systems, regulatory compliance, and inspection readiness. Based in Le Locle , Switzerland, the Sr Director partners closely with Site Leadership, Operations, Regulatory, and Corporate Quality to safeguard product quality, patient safety, and business continuity while driving a culture of quality excellence and continuous improvement. Key Responsibilities Leadership & Strategy Provide leadership and direction to site Quality Assurance teams, including direct oversight of Site Quality leaders. 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. People Development Develop and mentor Quality leaders and team members across sites, building strong succession pipelines. 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. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.