Specialist, Quality Compliance

Joining Integra LifeSciences is a chance to do important work that creates change and shapes the future of healthcare. The Quality Compliance Specialist will provide quality compliance support to the Collagen Manufacturing Center (CMC) Plant and ensure compliance with company policies and procedures, US. Food and Drug Administration Regulations, ISO 9001, ISO 13485:2016 Standard, European Medical Device Directives, Canadian Medical Device Regulations, and other applicable regulatory agencies.

Requirements

• Review and approve quality documents requiring QA oversight (e.g., IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier Quality Assessments, Supplier Corrective Action Reports (SCAR), alert and action reports, purchasing specifications, etc.)
• Prepare and compile metrics for Quality Management Reviews
• Serve as the quality compliance representative for project teams
• Participate on new product development project teams as quality compliance representative
• Support investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary
• Provide guidance for Product Development, Operations and Engineering teams on project development activities to ensure they conform to internal SOPs
• Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
• Review product and process changes for impact on existing notification requirements, for conformance with Design Control regulations and standards, and internal Standard Operating Procedures
• Provide support in FDA inspections, ISO audits and customer audits at the CMC facility

Benefits

• Medical
• Dental
• Vision
• Life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• Savings plan (401(k))