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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.
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.
Regulatory & Inspection Readiness
Ensure ongoing compliance with applicable regulations and standards, including FDA QSR, ISO 13485, EU MDR, and other global regulatory requirements.
Review, approve, and ensure timely and effective responses to inspection observations, including FDA 483s, audit findings, and warning letters.
Operational Quality Support
Provide Quality leadership for deviations, investigations, product impact assessments, and product release decisions.
CAPA & Continuous Improvement
Strong working knowledge of global Quality and regulatory requirements, including FDA QSR, ISO 13485, and EU MDR.
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.
