Jobs at Integra LifeSciences

Supervises QC microbiology laboratory operations, including microbiological testing, environmental and utility monitoring, cleanroom qualification, validation, investigations, data integrity, documentation, and inspection readiness. Leads laboratory personnel, manages testing priorities and external laboratories, reviews quality records, supports product and process validation, oversees equipment and supplies, and drives compliance and continuous improvement under FDA, ISO 13485, GMP, and GLP requirements.

Supports medical device manufacturing and engineering operations by managing investigations, CAPAs, nonconformances, risk management, validations, audits, and quality records. Applies FDA and ISO requirements, statistical tools, SPC, sampling, and data trending to improve processes. Supports new product introductions, transfers, complaints, post-market surveillance, regulatory submissions, and continuous improvement while collaborating with manufacturing, engineering, regulatory, supply chain, and operations teams. This is an on-site role.

Supervise QC analytical laboratory operations supporting raw material, in-process, stability, validation, and finished-product testing. Lead personnel, workload planning, data review, investigations, method validation, laboratory systems, equipment qualification, documentation, vendor laboratories, inspections, and continuous improvement. Ensure compliance with FDA regulations, ISO 13485, GMP, GLP, data integrity, safety, and company quality systems while partnering cross-functionally with Manufacturing, QA, Engineering, and Product Development.

Support and coordinate the corporate internal quality audit program: schedule and plan audits, manage logistics for onsite/remote audits, draft and manage audit reports and approvals, track CAPAs and action items, maintain audit records and metrics, support auditor training/certification, improve audit processes (TrackWise), and assist site inspection readiness.

Lead and develop global quality microbiology teams to ensure compliant microbiology programs across manufacturing sites. Oversee environmental and water system monitoring, endotoxin and bioburden test validation, contamination control, audits/inspections, cross-functional collaboration, and strategic microbiology process ownership to support manufacturing transfers, new products, and regulatory compliance.

Lead enterprise Quality Data Analytics strategy and programs for medical devices. Build and manage analytics teams, establish governance and reporting standards, ensure regulatory-ready analytics (FDA, ISO, EU MDR), support inspections, drive cross-functional collaboration, automation, and advanced analytics to enable proactive quality compliance, risk management, and program delivery across CAPA, complaints, audits, supplier quality, and post-market surveillance.

Lead functional design, configuration, testing, and post-implementation support for Oracle ASCP and Cloud Demand/Supply Planning. Drive requirements gathering, fit-gap analysis, integrations, reporting, validation for life-sciences clients, and deliver training and change management.

Lead hands-on Oracle EBS finance and cost accounting functional work across Record-to-Report. Configure and support GL/AP/AR/FA/SLA and costing, perform reconciliations, drive period close, create functional specs, support testing and integrations, analyze production issues, and identify process and reporting improvements to ensure accurate close, controls, and compliance in a regulated environment.

Lead, plan and perform corporate QMS audits across design, manufacturing and distribution sites to ensure compliance with GMP/GDP/GCP/GLP/ISO and regulatory requirements. Lead audit teams, produce objective technical audit reports, assess CAPAs, support inspection readiness, provide SME consulting and drive continuous improvement across global sites.

Lead design and implementation of the global medical device quality system, drive compliance with FDA, ISO 13485 and other international regulations, manage corporate quality teams (CAPA, document control, audits, post-market), support regulatory interactions, and deliver quality transformation across facilities.

Support EHS programs for a GMP-regulated medical device cleanroom site. Ensure OSHA, EPA, FDA and ISO compliance; manage chemical and hazardous waste, conduct JHAs and incident investigations, partner with Quality on audits and training, and drive continuous improvement in safety and contamination control.