Director, Site Quality

Integra LifeSciences

About The Position

Changing lives. Building Careers. Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY The Site Quality Leader is responsible for overseeing all quality and compliance activities at the Columbia manufacturing site and CMOs. This role provides strategic and operational quality leadership to ensure adherence to corporate policies and regulatory requirements. This leader will ensure robust quality systems, adherence to and efficiencies in quality processes, improve inspection readiness and oversee quality for external manufacturers. Reporting to the VP, Quality Operations TT division, the Site Quality Leader serves as the primary quality authority for the site, ensuring product quality, regulatory compliance, and alignment with the company’s Compliance Master Plan (CMP) and Quality Management System (QMS). ESSENTIAL DUTIES AND RESPONSIBILITIES Quality Leadership & Strategy Provide strategic direction for all site quality functions, ensuring alignment with corporate quality objectives and regulatory expectations. Drive the timely execution of critical corporate initiatives and programs. Lead the development, implementation, and continuous improvement of site quality systems, processes, and metrics. Serve as the site’s senior quality representative during regulatory inspections, internal audits, and customer audits. Champion a culture of quality, compliance, and operational excellence across all site functions. Quality Systems & Compliance Ensure full compliance with FDA, ISO 13485, CMDR, EU MDR, JPAL, and other applicable regulations. Oversee the effectiveness of key quality system elements, including CAPA, nonconformance management, change control, document control, internal audits, training, and risk management. Drive timely and effective remediation of quality and compliance gaps, including those identified through the Compliance Master Plan (CMP). Ensure robust supplier quality oversight in partnership with corporate Supplier Controls leadership. Manufacturing Quality Oversight Provide leadership for incoming inspection, in‑process quality, final release, and product disposition activities. Ensure that manufacturing processes are validated, controlled, and monitored to maintain product quality and regulatory compliance. Partner with Operations, Engineering, and Supply Chain to proactively identify risks, implement corrective actions, and improve process capability. Cross‑Functional Collaboration & Stakeholder Management Collaborate with Regulatory Affairs, R&D, Operations, Supply Chain, and corporate Quality teams to ensure alignment and consistency across the organization. Communicate quality performance, risks, and improvement plans to site leadership and executive stakeholders. Influence and guide cross‑functional teams to ensure quality considerations are embedded in all business decisions. People Leadership & Development Lead, mentor, and develop a high‑performing site quality team, including Quality Engineering, Quality Assurance, and Quality Control functions. Ensure the team has the skills, tools, and resources needed to meet quality and compliance objectives. Foster a collaborative, accountable, and continuous‑improvement‑oriented environment. Performance Management & Reporting Establish and maintain site quality metrics, dashboards, and reporting mechanisms. Monitor trends, identify systemic issues, and drive data‑driven improvements. Provide regular updates to senior leadership on site quality performance, risks, and strategic initiatives.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related technical field; Master’s degree preferred.
Minimum 12–15 years of experience in quality, manufacturing, or engineering within a regulated industry; medical device experience strongly preferred.
Demonstrated success leading quality teams and managing complex quality systems in FDA‑regulated environments.
Deep knowledge of cGMP, FDA regulations, ISO 13485, MDSAP, EU MDR, and other global regulatory frameworks.
Strong background in CAPA, root cause analysis, risk management, and process validation.
Proven ability to lead cross‑functional teams, influence stakeholders, and drive large‑scale quality improvements.
Excellent analytical, problem‑solving, communication, and presentation skills.
Ability to manage multiple priorities in a fast‑paced environment.
Up to 25–40% travel may be required depending on site and corporate needs.

Nice To Haves

Remediation and audit readiness experience preferred.
Master’s degree preferred.
medical device experience strongly preferred.

Responsibilities

Provide strategic direction for all site quality functions, ensuring alignment with corporate quality objectives and regulatory expectations.
Drive the timely execution of critical corporate initiatives and programs.
Lead the development, implementation, and continuous improvement of site quality systems, processes, and metrics.
Serve as the site’s senior quality representative during regulatory inspections, internal audits, and customer audits.
Champion a culture of quality, compliance, and operational excellence across all site functions.
Ensure full compliance with FDA, ISO 13485, CMDR, EU MDR, JPAL, and other applicable regulations.
Oversee the effectiveness of key quality system elements, including CAPA, nonconformance management, change control, document control, internal audits, training, and risk management.
Drive timely and effective remediation of quality and compliance gaps, including those identified through the Compliance Master Plan (CMP).
Ensure robust supplier quality oversight in partnership with corporate Supplier Controls leadership.
Provide leadership for incoming inspection, in‑process quality, final release, and product disposition activities.
Ensure that manufacturing processes are validated, controlled, and monitored to maintain product quality and regulatory compliance.
Partner with Operations, Engineering, and Supply Chain to proactively identify risks, implement corrective actions, and improve process capability.
Collaborate with Regulatory Affairs, R&D, Operations, Supply Chain, and corporate Quality teams to ensure alignment and consistency across the organization.
Communicate quality performance, risks, and improvement plans to site leadership and executive stakeholders.
Influence and guide cross‑functional teams to ensure quality considerations are embedded in all business decisions.
Lead, mentor, and develop a high‑performing site quality team, including Quality Engineering, Quality Assurance, and Quality Control functions.
Ensure the team has the skills, tools, and resources needed to meet quality and compliance objectives.
Foster a collaborative, accountable, and continuous‑improvement‑oriented environment.
Establish and maintain site quality metrics, dashboards, and reporting mechanisms.
Monitor trends, identify systemic issues, and drive data‑driven improvements.
Provide regular updates to senior leadership on site quality performance, risks, and strategic initiatives.

Benefits

employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

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