• Provides guidance and support for back-room activities during external audits. Recent audits included FDA, Corporate QMS, and 2 Customer audits.• SME for deviations, CAPA, Change Control, and Training• Management of Quality Events in Trackwise– • Deviations- assignment and oversite of record completion and metrics trending. Resulted in a reduced time to closure of deviation records.• CAPAs- Ran CAPA review board meetings, assigned reviewers, tracked, and trended metrics. Reviewed and approved extension requests. Resulted in a 15% reduction in overdue CAPA records. • Change Controls- Ran Change Review board meetings, assigned quality reviewers, tracked, and trended metrics. Reviewed and approved extension requests. Resulted in a 20% reduction in overdue change control records.• Overdue Effectiveness Check records closures reduced from 98 to 15 within 2 months. • Provided guidance and support to cross-functional teams on quality system requirements, best practices, and compliance issues. • Facilitated the review and improvement of the batch record review process to reduce the time from batch completion, through review and to product release. Batch record release average review reduced by 3 days.• Managed the collection and review of deviation, CAPA, Change Control and Training Quality Systems records.• Annual Product Quality Review for three product lines.• OOS investigations• Manage training department initiatives – • Project Management of the implementation on new training software (Noverant)• Oversaw the configuration of the training software.• Improved the organization of quality system training requirements• Updated site cGMP training material• New hire orientation process- revised and updated • Author and revise quality documentation• Improved accuracy of root cause analysis trend data• Improved review of deviations for escalation to CAPAs, resulting in reduced number of failed Effectiveness Checks.

• Quality system manager- creation and implementation of Quality System Procedures• ISO 13485• ISO 17025• Creation and implementation of site training requirements • eQMS (Master Control) software configuration• Document Control module• Training module• CAPA module• Audit module• Facility registration with the FDA• Coordination of site certification audit plan with a Notified Body• Remote audit of Japanese contract manufacturer

• Global corporate compliance oversite of audit responses and high risk CAPAs for compliance to 21 CFR 820 (GMP), ISO 9001, ISO 13485, ISO 14971, EU MDR, MDSAP regulations as well as Clinical requirements.• Managed training requirements and implementation for global Q&R personnel.• Corporate review and approval of CAPAs throughout all divisions globally.• Initiated a proactive tracking system to facilitate timely resolution, closure and relevant effectiveness checks.• Initiated a color-coded tracking system for enhanced review of CAPA record status.• Regulatory FDA system updates • device listings • facility registrations• state registrations. • export certifications.• Supporting third party backroom audit activities.• Compilation, review, tracking and submission of records to the front room during FDA consent decree monitoring audits.

• Review and approval of corporate level audit responses/ corporate CAPAs in relation to 21 CFR, ISO 9001, and ISO 13485 regulations as well as corporate requirements. • Responsible for initiating contact with worldwide facilities regarding audit resolutions and CAPA.• Assisting global Q&R personnel with FDA related databases.• Maintenance and submission of CAPA metrics both weekly and monthly.• Created new individualized chart for Q& R employees to monitor CAPA metrics.• Assisted in the creation of corporate wide CAPA training materials.• Assisted with the review and update of site FDA registration data for sites worldwide.• Assisted in the maintenance and update of Q&R intranet pages.

Review and approval of corporate level audit responses/ corporate CAPAs in relation to 21 CFR, ISO 9001, and ISO 13485 regulations as well as corporate requirements. Responsible for initiating contact with worldwide facilities regarding audit resolutions and CAPA.Assisting global Q&R personnel with FDA related databases.Maintenance and submission of CAPA metrics both weekly and monthly.Created new individualized chart for Q& R employees to monitor CAPA metrics.Assisted in the creation of corporate wide CAPA training materials.Assisted with the review and update of site FDA registration data for sites worldwide.Assisted in the maintenance and update of Q&R intranet pages.

• Creation and implementation of the Document Control System. • Created, implemented, and managed site internal audit program, including initial site certification to ISO 13485.• Created and implemented Quality System Training requirements• Supervision of documentation personnel• Training and management of internal auditors.• Creation and implementation of the supplier audit process.• CAPA Review Board team member. • Creation and implementation of the record retention process.

• Corporate Quality System auditor responsible for performing audits at national and international facilities according to ISO 13485, MDD, ISO 9000 and QSR regulations. • Managing the corporate audit planning and coordinating audit activities with international facilities.• Review and closure of audit responses as well as review of corporate CAPAs. • Reporting corporate audit metrics to Corporate Management.• Monitor FDA website for industry trends.

• Management of the Documentation Control system as well as supervision of document control personnel. Validation of Document Control System and records as required for implementation of new software.• Creation and implementation of the internal audit schedule as well as facilitating corporate site audits. • Internal auditor for ISO 9001 and 21 CFR• Creation and implementation of a facility wide calibration system. • Supervised the printing and release of product labeling.• Creation and oversight of product stability study, including supervision sample collection, sampling, and testing.• Reviewed BOMs in relation to the product life cycle and obsoletion of expired documentation

Supervision of Quality Control personnel, multishift manufacturing.Coordination and analysis of R&D test batches.Member of product development team.Control of production and inspection documentation.Coordination of calibration activities with contract calibration firm.Quality oversite of product labeling.Coordination of feeding studies with contract laboratory.

• Performed analytical testing and release of production batches.• Supervision of Quality Control personnel across multiple shifts.• Inspection of incoming packaging material and related supplier management to resolve non-conforming material issues.• Instrumental in creation and implementation of changes to SOPs, records, and training during implementation of ISO 9000.• Document control process • Creation and distribution of the company newsletter with emphasis on the introduction of ISO 9000.• Processing customer complaints.

• Inspection and labeling of incoming raw materials according 21CFR820• Processing blood samples for cell culture and denaturing as required for fluorescence in situ hybridization (FISH) product testing.• In process and final product testing of genetic chromosome markers for FISH IVD test kits.• Quality review of new product software used for the electronic inspection and documentation of chromosomal test results.

• Analytical testing of in process production batches.• Final product inspection.• Verification of in process automated inspection results.