Teams 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.