Quality Systems Specialist

About the role

Evolution Free Zone is listing this role for its client, Trelleborg Medical Solutions. The Quality Systems Specialist supports manufacturing processes within a regulated medical device environment and maintains the Quality Management System (QMS) to ensure compliance with regulatory, quality, company policies and manufacturing requirements.

Responsibilities

• Support internal audits, ISO notified body audits, customer audits and FDA inspections. Serve as an internal auditor and create and maintain the internal audit schedule.
• Audit controlled document files in preparation for regulatory inspections and provide support during regulatory inspections and client audits.
• Initiate and execute audits by developing and documenting the audit plan, leading the audit, generating the audit report and tracking subsequent actions with the team.
• Support external audits, including scheduling, hosting and preparing audit responses.
• Work with subject matter experts to ensure audit record content is accurate, well documented and meets process requirements.
• Develop metrics and perform trend analysis of key quality system areas, including internal and external audit findings, CAPAs, nonconforming material, training and deviations. Escalate trends to an appropriate quality system, such as CAPA or CI, and present analysis to management.
• Support maintenance of the CAPA program and serve as CAPA owner as needed, driving investigation, correction and corrective and preventive actions.
• Ensure internal and external audit findings are entered into the CAPA system, assigned to appropriate personnel and completed within specified time periods and in accordance with CAPA procedures.
• Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities.

Datos clave

• The role supports manufacturing processes within a regulated medical device environment.
• The role focuses on maintaining the Quality Management System (QMS).
• Responsibilities include internal audits, external audits and CAPA activities.