The Quality System (QS) Lead Auditor is responsible for the proper execution of the Quality Management System (QMS) audit program. The QS Lead Auditor is a subject matter expert on the Interpretation, implementation, and assessment of QMS processes against ISO 9001:2015, customer and government requirements. The QS Lead Auditor will work with the Quality Director to plan and execute compliance and process audits and associated corrective and preventative actions in support of all Quality Management System (QMS) and continuous improvement objectives.This position requires an interface with employees and leaders across sites. Process improvement initiatives, corrective action execution, and verification of effectiveness activities will be required. Fundamental to the QS Lead Auditor's responsibility is an expert-level interpretation of ISO 9001:2015 requirements and their application within business processes throughout the site
Responsibilities, duties, of the successful candidate, may include, but are not limited to:
Develop and executing a robust Audit Program in accordance with internal policies, government regulation, and certifications standards.
Facilitate the maintained of all required certifications for the site (ISO 9001:2015, EN ISO/IEC 80079-34, N299.2-16 16)
Ensure the Audit Program is successful in performing audits in accordance with professional practice standard, drafting audits checklist and reports, presenting issues and discussing practical solutions.
Maintain relationship with cross-functional segments, customer and external auditors and facilitate follow up activities when required
Report audit report results to the Management, including associated process improvements needed to strengthen the QMS
Use analytical methods and root cause analysis techniques, including, but not limited to these areas: 1) research and investigate process improvement opportunities; 2) recommend corrective and preventive actions; 3) conduct follow-up on corrective actions as needed to ensure sustainment occurs.
Experience Required: 3 minimum experience functioning as an internal quality auditor in a fast-paced quality/manufacturing environment. Knowledge of ISO9001:2015, is required.Skills
Strong organizational and communication skills (written and oral).
Experience in planning, scheduling, implementing, and conducting Internal Audit
Experience initiating, reviewing, and approval of Corrective Action responses and evaluate the effectiveness of implemented corrective actions
Proficient in Microsoft Office application (Word, PowerPoint, and Excel)
Ability to work independently
Strong personal skills interacting with internal and external customers
Self-directed and highly motived with strong closure skill
Bachelor's degree or equivalent in quality, business, or engineering plus 3-5 years experience in quality or reliability disciplines.
Formal ISO 9001 Lead Auditor training is preferred; including 3-5 or more years of experience with ISO 9001:2015
Six Sigma Green Belt (or equivalent) certification is desired.
Ability to perform risk assessments to identify audit areas and recommend plans.
Familiar with business process flows in a typical manufacturing entity.
Must be energetic, self-driven yet a strong team player with a positive attitude.
ASQ certification desired
Must have strong communication skills, both verbal and written, and positive interpersonal skills with the ability to engage effectively across organizations to achieve lasting results.
Working knowledge of corrective and preventive action systems is highly desired.