Site Quality Systems Lead
Advanced Energy
- Denver, CO
- $70,000-90,000 per year
- Permanent
- Full-time
- Responsible for maintaining, improving, and executing internal, external (e.g., registrars) and customer audits.
- Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving.
- Execute routine and risk-based monitoring and auditing of relevant business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing, and risk assessment for the business.
- Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies as well as with all applicable regulatory requirements
- Support management reviews, defining agenda and capturing meeting minutes. Generates metrics and trend reports, as necessary.
- Oversee internal auditing and supplier quality programs, including scheduling and participating in audits, to ensure compliance with appropriate quality standards and regulations.
- Develop internal auditing tools and conduct internal audits and reports.
- Maintain audit-related policies, procedures, and forms to ensure conformance with standards and continuous improvement of internal audit-related activities.
- Manage audit conduct or coordinates with local resources, communicates results and tracks corrective actions through completion.
- Ensure compliance with current regulations.
- Monitor and report on all activities, processes, and procedures.
- Determine data-driven solutions and implement quality improvement plans.
- Perform regular inspections and reviews to ensure employees adhere to quality and safety policies.
- Assist with the development of company policies, processes, and procedures, ensuring compliance to global requirements.
- Provide departments with quality planning and support.
- Conduct or assist with regulatory and quality training sessions.
- Manage and continuously improve the quality document control and corrective action systems and communicate system status through performance metrics.
- Manage and gain support for changes impacting the entire organization.
- Drive and maintain compliance to Enterprise Quality Management Systems.
- Audit multiple Design Centers to ensure compliance to applicable standards and drives corrective actions.
- Work in a standard office environment
- Audit activities will take place in all AE work environments, including manufacturing, service, and laboratory settings
- 30% domestic and international travel may be required
- Highly skilled auditor, able to conduct effective inquiry, investigation, and verification
- Deep understanding of the application of quality systems in product development, manufacturing, and service environments
- Ability to manage quality audit processes conforming to recognized standards (e.g., ISO 9001).
- Skilled at using statistical and non-statistical QA/QC tools to collect, research, analyze data and present to managers.
- Ability to effectively communicate with all levels of the organization with excellent written and verbal communication skills.
- Excellent SharePoint and Microsoft office suite program skills.
- Self-directed, ability to manage multiple priorities in a dynamic and sometimes ambiguous environment.
- Ability to enforce standards when applicable.
- Lead auditor certification from an (International Register of Certificated Auditors) IRCA organization, or ability to complete upon hiring, this includes the following standards (current version):
- 19011 (Auditing Guidelines)
- 9001 (Quality Management)
- 18435 (Medical)
- 14001 (EMS)
- Preparing, coordinating, and executing top level customer audits.
- 5 - 10 years auditing experience or combination of ISO, Manufacturing and Service industry knowledge.
- Previous manager experience.
- Ability to lead and influence all organization levels.
- Certification as a Quality Engineer and/or Quality Auditor with the American Society for Quality (ASQ) or other accredited business.
- BS in business or engineering / or equivalent experience in auditing.