Jobs at Integra LifeSciences

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.

Provide sterility assurance expertise across manufacturing, regulatory, and quality functions. Maintain sterilization and contamination-control programs, perform validations and audits, support EU MDR and FDA compliance, assess contract sterilizers, train staff, and author validation protocols, SOPs, and reports to ensure regulatory and technical compliance.

Serve as the primary HR leader for a manufacturing facility, partnering with business leaders on performance management, talent management, employee relations, organizational design, change management, compensation, workforce planning, and leadership development to drive business results and cultural transformation.

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.

Senior-level Design Quality Assurance engineer to lead risk management, verification/validation, statistical analysis, and quality system activities for medical device new product development and sustaining projects. Supports design reviews, FMEAs, DOEs, SPC, audits (FDA/Notified Bodies), documentation control, and continuous improvement while mentoring junior staff and coordinating cross-functional and external partners.

Lead global supplier and contract manufacturing quality strategy for a medical device company. Ensure regulatory compliance (FDA, ISO 13485, EU MDR, MDSAP), oversee supplier audits, qualification, CAPA, and risk-based monitoring. Drive process validation, PPAP/FAI, analytics-driven supplier performance, and enterprise quality transformation. Provide leadership to a global team, advise executives, and partner across Supply Chain, R&D, and Regulatory to ensure product safety and continuity of supply.

Support design and development of medical device products through risk management, design controls, verification/validation, statistical analysis, SPC/DOE, audits, and quality system documentation to ensure compliance with GMP, QSR, and ISO standards.

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 quality assurance for new product development and sustaining projects in Tissue Technology. Manage risk and usability engineering (FMEAs, PSRA, BRA), support verification/validation, SPC and DOE design, participate in audits/inspections, author quality system procedures, ensure compliance with GMP/QSR/ISO, and drive continuous improvement across cross-functional teams.

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.