Senior Director, Quality Operations EU

TheSr Director, Quality Assuranceprovides strategic and operational leadership for Quality Assurance across multiple manufacturing sites within the CSS organization at IntegraLifeSciences. Serving as a criticalspan‑breaker, this role oversees Quality operations for the LeLocle, St. Aubin, and RW sites, ensuring consistent execution of global Quality systems, regulatory compliance, and inspection readiness. Based in LeLocle, Switzerland, theSrDirector 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 LeLocle, St. Aubin, and RW sites.

• Translate global Quality strategy into effective site-level execution aligned with Integra policies and businessobjectives.

• 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 ensuretimelyescalation 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 ensuretimelyand 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 whilemaintainingcompliance and quality standards.

• Provide Quality leadership for deviations, investigations, product impact assessments, and product release decisions.

• Ensureeffective changemanagement 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 >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.