Integra LifeSciences · 5 days ago
Director, Site Quality
Columbia, MD
Full-time
Onsite
Director/Executive
$167K/yr - $229K/yr
12+ years expIntegra LifeSciences is a company focused on innovating new treatment pathways to advance patient outcomes in healthcare. The Site Quality Leader is responsible for overseeing all quality and compliance activities at the Columbia manufacturing site and ensuring adherence to corporate policies and regulatory requirements while leading a high-performing quality team.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
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. Remediation and audit readiness experience preferred
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
Preferred
Master's degree
Remediation and audit readiness experience
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase