Manage corrective action, continuous improvement, and training activities. Develop and maintain quality performance metrics. Manage internal audit program and perform internal audits based on AS9100 and ISO 9001:2015 standards. Evaluate documents and records to establish conformance with quality management system requirements.

Primary responsibility for the daily oversight and maintenance of Sterling’s AS9100 Quality Management System.• Lead quality/business management system (QMS/BMS) improvements and modifications to improve effectiveness and compliance to AS9100, ISO 9001, FAA, and EASA requirements.• Audit program leader; internal, customer and 3rd party (AS9100) supporting system and process continuous improvement.• Created, maintained yearly internal audit schedules. Trained new auditors on best audit techniques, lead and mentored audit team.• Lead implementation and standardization of quality system requirements for New Product Introduction across multiple programs.• Coordinated with staff across the organization to secure buy-in and participation from al levels throughout implementation and execution of strategic initiatives.• Ensured product-related and facility deviations/CAPAs were initiated, investigated, and resolved. Reviewed and approved Change Control, Deviations, CAPAs as needed.• Responsible for Root Cause Analysis Team. Documented 8D reports for customer feedback and maintained Corrective Action system.• Developed, launched and managed employee working groups responsible for creating strategies and tactics and implementing corrective action initiatives meant to accomplish Key Performance Indicators (KPIs).• Supported and integrated Product Lifecycle Management in compliance with industry standards for document control and configuration management.• Developed new hire and recurrent training pertinent to the Quality Management System including but not limited to: Internal Auditor, Corrective and Preventive Action (CAPA), Electro Static Discharge (ESD), Control and Handling Non-Conforming Material, cGMP, Foreign Object Damage (FOD), etc.• Wrote, reviewed, revised and/or prepared quality documents (SOPs, works instructions, process flow maps, customer communications, emails) in accordance with cGMPs and regulatory guidelines.

• Served as primary point of contact for customers on significant quality events ensuring deviations, investigations, CAPAs and Change Controls are timely addressed and closed.• Worked with Senior Management team and key staff to adopt and implement corporate quality plan.• Interfaced with manufacturing, engineering, and suppliers to ensure that quality, customer and regulatory requirements were met and properly documented.• Lead process improvement planning in a Team based environment.• Maintained process quality audits and internal audits of the QMS.• Coordinated all aspects of customer visits, reports, audits, preparation and corrective action resulting from audits.• Facilitated quality system process development activities in accordance with AS9100, ISO9001 requirements.• Monitored incoming material quality and works with supply chain to improve as-received quality levels. Established supplier auditing process to mitigate escapes.• Provided support for failure analysis and reliability testing as required.• Managed MRB process by driving timely root cause analysis and implementation of preventive corrective actions for quality issues.• Reviewed quality document changes (e.g. ECNs, standard operating procedures, work instructions).

Performed internal audits of processes, performed external supplier audits of their quality systems and processes, follow-up on corrective action progress and/or effectiveness for audit non-conformances, prepared internal and external audit schedules, served as an internal compliance/regulation expert and communicated applicable regulation changes to the organization.