Job Information
Integra LifeSciences Quality Systems Analyst in Irvine, California
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Under supervision, general direction, and in accordance with all applicable federal, state and local laws/regulations and Corporate Integra, procedures and guidelines, this position is:
Responsible to implement, revise, execute, and maintain CAPA and NCR procedures including the Stop Shipment process.
Responsible for communicating quality and business-related issues or opportunities to next management level.
Responsible to comply with all Federal, State, local and company regulations, policies and procedures including Health, Safety and Environmental compliance.
Actively participate and engage in CAPA trending meetings.
Work on complex investigations and coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA actions.
Follow up with action owners on all action items until items are effectively completed and closed.
Track and provide monthly Quality System Performance Metrics.
Act as CAPA, NCR and Stop Shipment Subject Mater Expert (SME).
Provide instruction and training to associates on requirements and best practices for Quality Systems
Where required, provide back room support for internal, third party, and regulatory inspections and audits as an SME for quality systems.
Perform administrative duties within the CAPA and NCR software systems.
Support and participate in cross-functional projects when assigned, facilitate technical innovations to enhance Quality Systems and support business goals, and assist with other Quality System activities as requested by management.
Identify opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives, as well as taking ownership of CAPAs impacting the NCR or CAPA Quality System.
Performs other duties assigned as needed
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed