Quality Systems Analyst

Supermicro•San Jose, CA

13d•$68,640 - $74,000

About The Position

This position works directly with multiple teams to support the development and implementation of a proactive Quality Management System (QMS), Environmental Management System (EMS), and Information Security Management System (ISMS). This includes the creation, training, deployment, auditing, and maintenance of the global Supermicro Quality and Environmental Managements Systems. Modify, update, and maintain records and documentation pertaining to site certification under ISO 9001 / 13485 / 14001 / 27001. The Quality Systems Analyst will be responsible for the local site's QMS, EMS, ISMS and other related management systems.

Requirements

Bachelor's degree in related field required and 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).
Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse.
May require domestic and international travel (10-20%).

Responsibilities

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, including but not limited to the following;
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 pertinent 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;
Detailed review of ISO controlled documents in order to ensure its adequacy;
Assists in the gathering, trending and reporting of performance indicators and reporting the status to management;
Serve as the process owner and subject matter expert for key elements of the QMS, EMS, ISM, including CAPA, Complaint Handling and Internal Audit.
Support the development of requirements, validation and implementation of automation projects to optimize the effectiveness of the QMS, EMS and ISM.
Execute and complete projects and other duties as assigned.