•Site Deputy Quality Management Representative for medical devices under ISO 13485:2016 and 21 CFR §820• Established and implemented the site Internal Audit program• Established and implemented an EH&S department• Responsible for the Internal Audit program and the Layered Process Audit program• Responsible for the 5S program• Responsible for the day-to-day guidance, scheduling and direction of the site Senior Quality Assurance Coordinator, the calibration department, the final acceptance department and the EH&S department• Lead Auditor for internal and external audits• Design, development and implementation of the site's QMS onboarding process for new employees

• Maintains efficacy and compliance of Orchid’s electronic quality management system applications.• Oversees implementation of Orchid’s corporate quality system procedures and work instructions to ensure ongoing compliance.• Supports Orchid manufacturing facilities day-to-day quality operations, as required• Assists with respect to the completion of site-specific QMS deliverables including, but not limited to the following subsystems: customer complaints, CAPA, nonconforming material, and process/equipment/software validation• Administers quality system training curriculums and oversees overall training execution for Orchid’s corporate employees.• Acts as the Subject Matter Expert (SME) for Orchid’s global Internal Audit program to ensure ongoing compliance, which includes performing Internal Audits at Orchid manufacturing facilities as requested • Conducts corporate Management Review meetings to ensure ongoing compliance and effectiveness of the Orchid quality management system• Gathers and analyzes quality metrics using a variety of software-based tools, including but not limited to statistical software, MS Office Suite, and PowerBI• Builds strong relationships with employees at all levels of the organization across multiple functional groups to support Orchid’s culture of quality.• Authors, Reviews, and/or Approves corporate procedures and work instructions, where required, to support the ongoing effectiveness of the Orchid quality management system• Acts on other quality-specific duties, tasks, and responsibilities as assigned or required

• Established, implemented and maintained a global internal audit program compliant to ISO 13485 and21 CFR 820• Coordinate annual training/onboarding for new auditors across the globe• Conduct site internal audits• Audit nonconformance follow-up and monitoring• Assist site Quality Managers with internal and external audit nonconformance responses as needed• Maintain and continually improve the audit scheduling, reporting and nonconformity databases(PowerBI, Excel, ETQ Reliance, Mendix)• Develop internal, supplier and external audit-related procedures, work instructions, forms and training for global implementation• Corporate document control administrator (MQ1)• Global document control system point of contact• Corporate ComplianceWire administrator, support for regional and site-level administrators; HRIS liaison• Project Manager for corporate Management Review presentations• Project Manager and customer liaison for EU-MDR documentation requests

•Site Quality Management Representative for medical devices under ISO 13485:2016 and 21 CFR 820• Established and implemented the site Internal Audit program• Established and implemented an EH&S department• Responsible for the Internal Audit program and the Layered Process Audit program• Responsible for the day-to-day guidance, scheduling and direction of the site Quality Systems Leader ,the calibration department, the final acceptance department and the EH&S department• Lead Auditor for internal audits• Design, development and implementation of the site's QMS onboarding of new employees

Full responsibility for the corporate quality department and quality auditors.Oversight of all Quality Management Systems and procedures for ISO 9001, ISO 13485, ISO 17025, ISO 17034, ISO 17043.Quality Management Representative for the company.

Supervise and conduct training on :Quality, FDA, ISO and cGMP compliance operations. Regional Medical Device Gas Quality Representative, local ISO 9001 Quality Management Representative, specialty gas lab manager, Quality Control Unit supervisor.

Fill, analyze and package specialty gases and medical cases.