Job title: Quality Engineer III
Location: Raynham MA
• Support the implementation of the standardized procedures, processes and systems for CAPA and NC (Project improvements)
• Supports CAPAs and NCs owners through the stages of the CAPA & NC process.
• Provide guidance to all associates at the site (internal and contractors) about the CAPA and NC requirements as well as other European Sites
• Deliver education and interactive training for CAPA & NC users to deliver consistent compliant CAPAs and NCs including Failure Investigation, CAPA Review Board and CAPA/NC content; Train and engage the involved associates in the CAPA & NC process
• Assist CAPA & NC users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination
• Collaborate in the identification and implementation of corrective actions; Ensure effective and timely completion of all corrective actions
• Reviews CAPAs and NCs to ensure compliance to CAPA and NC procedures and Ensures that the CAPAs and NCs will be implemented according to the regulatory (e.g. ISO 13485, 21 CFR 820) and internal requirements
• Maintain overall management and effectiveness of the CAPA and NC system including the process and application for applicable location, Roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes
• Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA, Compile and analyze the NCR data and develop proposals for improvements
• Liaise with CAPA Management Team in establishing and implementing policies, procedures, and quality objectives
• Liaise with the CAPA Management Team to align on system requirements to support the CAPA process; Identification and leadership of tactical continuous improvement opportunities; Identify opportunities for procedural harmonization and integration;
• Support audit readiness for CAPA and NC; Partner on the formulation of responses to regulatory agencies in order to address CAPA and NC related observations
• Support across Quality Systems Management when required to ensure compliance across the business.
• Responsible for leading project teams and managing all activities for data gathering analysis and implementation of CAPAs and NCs to ensure compliance.
• Liaises with sites and operating companies to ensure adherence to CAPA and NC processes
• Facilitates change management activities resulting from the standardization of CAPA and NC processes