Address
Form of work
SalaryDescription
- Maintains and updates CAPA policies, procedures and tools and ensures training provides thorough instruction for consistency and compliance across many departments.
- Provides continuous and rigorous assessment of site/s CAPA activities and documentation to ensure compliance with CAPA processes, FDA regulations, ISO 13485, ISO 9001, and medical device requirements through the review of CAPA records.
- Provides guidance and mentors CAPA owners, CAPA leads and CAPA team members regarding the CAPA process, CAPA best practices,
- Works cross-functionally with a sense of urgency to ensure timely, compliant, and effective CAPA records.
- Supports internal and external audit activities and work to resolve audit nonconformities.
- Support coordination of investigation, including investigation plans, and cross functional discussions, and root cause analysis.
- Provides expertise in the application of quality tools including process mapping, problem solving, and root cause verification and the creation of system solutions for CAPA.
- Assesses and identifies risk and evaluates deficiencies while partnering with system owners to develop remediation plans.
- Work with SMEs for a thorough assessment of CAPA activities and documentation to ensure technical consistency and accuracy and compliance with medical device regulations, company standards and procedures. Collaborates with other site CAPA administrators to leverage shared opportunities for improvement and best practices.
- Monitors and reports metrics for the CAPA system including on-time closures.
