Provide ongoing consulting services to clients in Medical Devices and In Vitro Diagnostics in the development and management of their Quality Management Systems (QMS) to ensure alignment to the latest standards and regulations and achieve a high level of compliance.Projects include:• Interim site quality leader responsible for the development of a Quality Management System aligned with FDA Emergency Use Authorization (EUA) and ISO 13485 for an In-Vitro Device manufacturer of Molecular Assays for the detection of nucleic acid from SARS-CoV-2. Lead Quality Systems and Quality Assurance operations, hire and establish a Quality organization, and support overall growth of the global QMS. Develop a strategy and quality plan for site remediation activities of EU IVDR requirements.• Development and ongoing Management of a Quality Management System aligned with ISO 9001 for an importer and distributor of drug infusion pumps.• Manage Document Control, Training, and CAPA systems for an ISO 13485 certified medical device manufacturer of a wearable medical device for tracking of vitals like temperature, oxygen saturation, and blood pressure. Implementation, migration of documents and records, and management of Greenlight Guru eQMS.• Implementation of Greenlight Guru electronic Quality Management System (eQMS) for multiple clients.• Quality Systems Development, and Management for a leading calibration gas and specialty gas manufacturer. Implementation of a micro GMP/QMS to meet class 1 exempt calibration gas requirements.• Conduct Risk Management activities aligned to ISO 14971:2019 and Complaints Management for an organization that provides innovative personal protection equipment and infection control solutions for use in operating room settings, and for an organization that design and develops a medical device for minimally invasive treatments of LSS (lumbar spinal stenosis).• Perform supplier audits in accordance with MDSAP, ISO 13485, and/or ISO 9001 standards.

Avanos Medical, formerly Halyard Health / Kimberly Clark / I-FlowPlan, direct and conduct activities that ensure quality systems remain in compliance to evolving regulatory requirements and in support of production of quality product. Ensure the effective and efficient global deployment of Quality Systems to EU MDR, ISO13485:2016, and MDSAP requirements. Coaching and mentoring Quality and business leaders at manufacturing sites to increase technical understanding of Quality Systems, ISO13485:2016, and MDSAP requirements. Host notified body audits for Acute Pain sites and provide leadership and onsite support to manufacturing sites during regulatory body audits.Accomplishments include:• Led the EU MDR gap assessment for QMS and directed remediation activities (2019).• Developed interactive MDSAP training tool and deployed it to global sites (2018).• Implemented ISO13485:2016 to all sites by leading gap assessment and remediation activities (2017).• Hosted first Avanos (Halyard) MDSAP Notified Body audit (2016) with zero (0) major nonconformities and developed gap assessment and training program for all manufacturing sites. Actively led or supported subsequent MDSAP audits at Avanos corporate and manufacturing sites.• Developed the Learning Management System (LMS) strategy for the entire organization using ComplianceWire (2015) and Success Factors (2018).• Led and participated in the development of EtQ (Excellence through Quality) electronic Quality Management System (QMS), including modules for CAPA, Nonconformities, Supplier Management, Change Management, and Deviations (2013-2018).• Hosted yearly (2013 to present) Notified Body audits with zero (0) major nonconformities.• Key member in the response team for FDA 483 with 10 observations (2013). Developed strategy for integration of CAPA process into electronic QMS (EtQ) for CAPA documentation and handling. Develop a supplier audit schedule using a risk-based approach.

Halyard Health, formerly Kimberly-Clark. Halyard Health was subsequently re-branded as Avanos Medical.Refer to Description for Avanos Medical.

I-Flow Corporation, a Kimberly-Clark company. I-Flow and Kimberly-Clark Healthcare was subsequently spun off as Halyard Health and later re-branded as Avanos Medical.Refer to Description for Avanos Medical.

Provide leadership in the implementation, maintenance, and improvement of companywide quality management systems and support processes. Monitor the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards.Manage the company’s document control / product lifecycle management (Agile PLM) system to ensure the efficient and effective processing of documentation in support of business needs. Provide technical expertise and support to internal functions, including international sites, in the application, maintenance and improvement of quality systems and department specific processes.

Management Representative responsible for implementing, updating, and maintaining the quality systems to support manufacturing operations and ensure compliance with current FDA and European Medical Device Directive. Hosted FDA and notified body audits and completed corrective and preventive actions and responses. Hands-on management of CAPA, complaints, internal audits, document control, Quality Assurance, and product removal investigations. Conducted all supplier qualifications and audits.Accomplishments include:• Assessed the Quality Management System (QMS) and led updates to support operating objectives while improving compliance. Significant updates included:o Rewriting the Design Controls and Risk Management procedures to ensure compliance with MDD as amended by the latest revisions of 2007/47/EC and ISO14971:2007.o CAPA processo Complaint Handling and Medical Device Reporting (MDR) process to meet the latest QSR, MEDDEV 2.12-1 and Canadian requirements.o Management Review processo Supplier Controls to ensure all supplier qualification and audit activities meet regulatory requirements.o Document Control to ensure proper documentation for all aspects of quality management system requirements.• Hosted FDA during QSIT inspection which resulted in no observations. Hosted FDA Laser Products inspection. Supported FDA BIMO audits.• Hosted all notified body (BSi) surveillance and recertification audits in support of CE Mark and Canadian license. Prepared and submitted all audit responses; responsible for assuring completion of all audit corrective actions.• Attained ISO 13485 lead auditor certification and led all supplier qualifications and supplier audits to ensure suppliers meet regulations and internal requirements.• Prepared and submitted annual regulatory reports such as FDA annual PMA report and Canadian licensing registration.• Established and led a team in assessing all regulatory correspondence to FDA/BSi.

Work with cross-functional teams performing gap analyses of quality systems and determining requirements for compliance with drug and device regulations. Implement required system enhancements and support documentation. Prepare the organization for an FDA regulatory agency audit in support of a new device/drug combination product. Develop and implement Quality Systems and associated documents by interpreting and applying regulations. Develop training materials and conduct training on quality system regulations and best practices. Accomplishments include:• Project Lead for Change Management System. Successfully implemented and provided support and guidance to users of Change Control process. Developed and conducted change management training.• Prepared audit questionnaire based on FDA regulations, ISO standards, and MedCert guidance to be utilized during mock audits. Conducted mock audits and area walkthroughs to ensure compliance with regulations and expectations prior to FDA and third-party audits. Assist in FDA and regulatory body audits by coordinating support room activities.• Developed and conducted audit conduct training to supervisors and subject matter experts.• Designed Quality System Regulations and Good Manufacturing Practices training for the organization; provided train-the-trainer classes and presented training to the organization.

Management of Product Complaints and CAPA departments. Perform Failure Investigations and Root Cause Analysis for in-house manufacturing issues and product complaints. Provide review and approval of product nonconformities, deviations, investigations, and audit observations. Review and approve validation protocols and Standard Operating Procedures. Provide guidance to business units for change control, validations, inspections, and Good Manufacturing Practices (GMP). Prepare technical investigative reports to management for product/process nonconformities or field performance issues (recalls). Represent company in contacts with customers and regulatory agencies, including interfacing with FDA inspectors.Accomplishments include:• Reduced backlog of Product Complaints from 167 in June 2004 to less than 40 in June 2005.• Contributed to a successful FDA PAI/GMP inspection in October 2004 resulting in approval of a new drug product.• Revamped CAPA and equipment / process validation program process and provided training and guidance to the organization.• Conducted process and equipment validation of aseptic drug filling manufacturing equipment.

Define process validation requirements and develop test plans (IQ/OQ/PQ) for cardiovascular products. Provide quality engineering support of production lines; review and disposition non-conforming products and components (MRB). Review and update Device Master Record documentation as required per change control procedures. Define quality control inspection plans, requirements, and methodologies. Train inspection and manufacturing personnel on new or modified processes or inspection requirements.

Define process validation requirements and develop test plans (IQ/OQ/PQ) for cardiovascular products. Provide quality engineering support for the launch of a drug coated blood reservoir. Conduct equipment, process and software validations, Failure Mode & Effects Analysis (FMEA), Microbiological/ Biological/ Chemistry submissions, statistical analysis, review and approval of manufacturing documentation, and failure analysis and corrective action. Completed company sponsored Six-Sigma certification course.