Jobs at Integra LifeSciences

Validate and maintain tariff and country-of-origin data, perform restricted party screening and ECCN classifications, support daily import/export operations and customs clearance, monitor regulatory changes, coordinate with cross-functional teams and external brokers, and support audits and continuous improvement of trade compliance processes.

Lead process improvement, sustainment, and lifecycle engineering for medical device manufacturing using lean and Six Sigma. Plan and execute validations (IQ/OQ/PQ/TMV), SPC analysis, FMEA, CAPA, and engineering change activities. Drive cross-functional projects to improve yield, reduce scrap, and ensure compliance with FDA, GMP, ISO 13485, EU MDR, and CMDR.

Coordinate inbound and outbound freight for healthcare products, manage 3PL and carrier relationships, arrange transport and rates, control documentation and PODs, monitor performance and costs, handle queries, invoicing and claims, and collaborate with warehouses and suppliers.

Lead QA activities for aseptic/sterile manufacturing including nonconformance investigations, CAPA, batch record and production quality support, sterility assurance (environmental monitoring and media fills), regulatory compliance (FDA/EMA/cGMP), audits/inspections, and mentoring QA staff to ensure product quality and continuous improvement.

Field-based Account Manager responsible for executing direct sales strategy to meet territory revenue goals. Train and support ENT surgeons in the OR, maintain CRM and quality records, manage planning tools and emergency stock reconciliation, develop physician market programs, and build local healthcare relationships. Requires extensive travel and territory-based coverage.

Lead, coordinate and perform corporate quality system audits across global medical device design, manufacturing and distribution sites. Produce evidence-based audit reports, identify and support remediation of nonconformities, drive inspection readiness, coach sites and stakeholders, support policy implementation and continuous improvement, and provide technical subject-matter expertise.

Senior commercial leader responsible for US marketing strategy and team leadership across ENT and Instruments. Drive product commercialization, launches, sales alignment, market development, KOL engagement, analytics-driven performance, compliance with FDA, and cross-functional collaboration to deliver revenue and market share growth.

Optimize and sustain medical device manufacturing processes using lean and Six Sigma tools. Lead validations (IQ/OQ/PQ/TMV), SPC, FMEA, CAPA, ECR/ECOs, process studies, and cross-functional projects to improve yield, quality, cost, and compliance with FDA, GMP, ISO 13485, EU MDR, and CMDR.

Sell and support Integra ENT products by learning product use, demonstrating in OR/ASC/private practice settings, handling customer questions ethically, executing the sales cycle, communicating opportunities to management, and supporting territory activities until promoted to full territory consultant.

Support supplier quality for Integra by planning and conducting supplier audits, maintaining supplier quality agreements and approved supplier lists, driving supplier corrective actions, supporting validation/verification and change control, and collaborating with QC, purchasing and production to ensure compliance with ISO standards, FDA regulations, and cGMP.

Lead quality engineering activities across product lifecycle including audits (ISO-13485/21 CFR 820), NC/CAPA investigations, risk management, process monitoring, statistical analysis, supplier issue resolution, and mentoring technicians/engineers to drive continuous improvement.

Manage sales of the Specialty Surgical portfolio in Swiss hospital accounts to drive revenue and exceed targets. Build long-term clinical and administrative relationships, support surgeries in the OR, lead tender/RFP activities, use Salesforce for pipeline and territory management, collaborate cross-functionally, participate in meetings, and manage budgets and product expertise.

Sell and support Integra Neurosurgery products within a defined territory by meeting sales targets, developing new business, providing consultative OR support (90% time in OR), building customer relationships, executing territory plans, and collaborating with cross-functional teams to ensure customer satisfaction and inventory/case coverage.

Manage and grow Integras burn accounts in Texas, educate burn clinicians and KOLs, support contracting and inventory, drive sales and training, and collaborate on clinical initiatives, research, and marketing to position Integra as the leading regenerative solution in burn care.

Lead a global team to optimize revenue capture, price contract management, and order release to ensure timely invoicing. Provide analytics, dashboards, and decision-support for pricing and contract compliance. Partner with sales, accounts, finance and product divisions to drive KPI development, consignment order management, process optimization, and operational excellence.

Lead APAC marketing and training for medical device products: build market insights, develop and execute marketing and launch plans, manage product lifecycle and promotional activities, coordinate product and distributor training, collaborate cross-functionally, and manage marketing budgets and related capital expenditures.

Provide QA compliance support for the Plainsboro CMC Quality System: review and track NCs, CAPAs, and Complaints; perform root cause investigations; train staff; prepare metrics; ensure regulatory compliance with FDA, ISO 9001/13485, MDD, and CMDR.

Lead a medical device manufacturing site overseeing safety, quality, manufacturing, supply chain, engineering, facilities, and finance. Serve as Value Stream Manager driving continuous improvement, regulatory compliance (FDA, ISO 13485, EU MDR, CMDR), KPI performance (safety, quality, delivery, cost), budget management, and cross-functional alignment to meet productivity and capacity goals.

Lead quality engineering for medical devices by reviewing designs and manufacturing processes, managing risk files, supporting validation and statistical analysis, ensuring compliance with ISO 13485/ISO 14971/FDA QSR and IEC 62304, and collaborating with cross-functional engineering teams to drive continuous improvement.

Responsible for optimizing and sustaining medical-device manufacturing processes using lean and Six Sigma tools. Duties include validation (IQ/OQ/PQ/TMV), SPC and statistical analysis, FMEA/CAPA, engineering change management, process monitoring and improvement, cross-functional project work, training, and supporting NPI and lifecycle activities in compliance with GMP, ISO 13485, and applicable regulations.