Support the implementation, maintenance and improvement of the QMS, EMS, ISM, procedures and department specific processes.
Plan, perform, assist in company-wide internal audit program, from planning, implementation, report generation, corrective action issuance, verification and closure.
Support external audits by the Notified Body, other regulatory bodies and third-party auditors.
Day-to-day management of the local ISO related activities and projects.
Work closely with all departments in regard to ISO implementation, issues, maintenance and improvement activities.
Coordinate appropriate and effective corrective and preventive (CAPA) actions in response to observations and findings from the audit program, external regulatory agency inspections, customer complaints and other internal/external non-conformances.
Document Control activities through the automated documentation system including training of associates to read, review and approve documents; and maintaining a fully compliant system.

Bachelor's degree in related field required
Minimum 2 years of relevant experience in quality system with experience in manufacturing and/or high-tech industry preferred
Experience in developing and leading quality and environmental management system audits in the semiconductor/electronics manufacturing, pharmaceutical or medical device industries.
Working knowledge of ISO International Standards, such as ISO 9001, 13485, 14001, 27001, AS9100, TS16949, etc.
Influence management skills; demonstrated ability to work constructively across all functions of the organization, including with customers and suppliers.
Strong communication and presentations skills (articulate and persuasive).
Sound organizational and multi-tasking skills.
Strong computer and analytical skills, including data analysis and reporting using Microsoft Excel, Access, Word, PowerPoint, Outlook, etc.
Knowledge of Risk Management (risk assessment tools such as FMEA, fault tree, etc.) and KPI (Key Process indicators).

Quality Systems Analyst – ISO

Key skills