Provides strategic and tactical leadership of Quality Engineering function. In-depth understanding of 21 CFR Part 820, 210, 211, 11, 822, ISO 13485:2016, and IVDR/MDR regulationsLead Auditor (IRCA/CQI certified) performing internal and external audits. Support audits (FDA, notified bodies, using MDSAP methodology). Certified to ISO 19011, 9001, 13485, 14971, 17025, AS9100 & China GMP, 21CFR Part 820, Part 11Manage, develop, and train Quality Engineers, MRB Coordinators, Instrument Plant Technicians, & QC InspectorsDevelops, modifies, applies and maintains quality standards and procedures in compliance with regulations and standards. Train various departments and associates in GMP & Quality System proceduresResponsible for all aspects (product /process) related to the quality of the Instrument Plant for the WH&C (Cancer) Class III IVD products. Includes manufacturability, BHR/DHR record release, supplier controls, customer requirements, management of product complaints and adverse event reportingCoordinates integration of new products into Manufacturing / Operations from NPD/R&DManages suppliers to resolve and prevent technical issues while working closely with Procurement to improve supplier performanceApplies SPC & CAPA tools to analyze data and identify root cause and problem resolution to prevent recurrence. Owner and individual contributor to CAPACreates and maintains maintenance of product risk files utilizing a risk based approach to product /production issuesSoftware management for releases compliant with IEC 62034 /FDA regulations for product software utilizing both waterfall and agile methodologies in the SDLCLeader of Post Market Surveillance for Women’s Health & Cancer Class III businessesResponsible for requirements of change management / change control for pre and post launch design changes. Deviation System design and reportingAlign and standardize business processes and best practices in each Quality System Business Unit

Provides strategic and tactical leadership of Quality Engineering function. In-depth understanding of 21 CFR Part 820, 210, 211, 11, 822, ISO 13485:2016, and IVDR/MDR regulationsLead Auditor (IRCA/CQI certified) performing internal and external audits. Support audits (FDA, notified bodies, using MDSAP methodology). Certified to ISO 19011, 9001, 13485, 14971, 17025, AS9100 & China GMP, 21CFR Part 820, Part 11Manage, develop, and train Quality Engineers, MRB Coordinators, Instrument Plant Technicians, & QC InspectorsDevelops, modifies, applies and maintains quality standards and procedures in compliance with regulations and standards. Train various departments and associates in GMP & Quality System proceduresResponsible for all aspects (product /process) related to the quality of the Instrument Plant for the WH&C (Cancer) Class III IVD products. Includes manufacturability, BHR/DHR record release, supplier controls, customer requirements, management of product complaints and adverse event reportingCoordinates integration of new products into Manufacturing / Operations from NPD/R&DManages suppliers to resolve and prevent technical issues while working closely with Procurement to improve supplier performanceApplies SPC & CAPA tools to analyze data and identify root cause and problem resolution to prevent recurrence. Owner and individual contributor to CAPACreates and maintains maintenance of product risk files utilizing a risk based approach to product /production issuesSoftware management for releases compliant with IEC 62034 /FDA regulations for product software utilizing both waterfall and agile methodologies in the SDLCLeader of Post Market Surveillance for Women’s Health & Cancer Class III businessesResponsible for requirements of change management / change control for pre and post launch design changes. Deviation System design and reportingAlign and standardize business processes and best practices in each Quality System Business Unit

• Developed, implemented, and trained associates to new/updated departmental operating procedures• Redefined complaint handling process for Diagnostics Systems and rolled out to worldwide regional designated complaint handling units and field service representatives. • Redefined the non-conforming material areas and process for quality notifications and trending to improve flow of material from receiving, incoming inspection to production using SPC techniques.• Create, own, investigate CAPA, Complaint Investigations, Quality Notifications, etc.• Responsible for developing and maintaining the Design History Files in compliance with international regulatory requirements • Reviews and approves product documentation, drawings, process and design verification/validation• Site Validation Leader for all plant related activities for equipment and instruments; reviewer and author of protocols and reports.

• Test Lead of embedded instrument systems including molecular, micro, immunoassay, and lab automation platforms. • Systems Engineering Core Team Member for Veritor Rapid Test System, Immunoassay Diagnostic Reader. Participates in FDA 510(k) submissions for moderately complex and CLIA platforms. • Systems Engineering and Project Lead Core Team Member Cytology and Molecular processing platforms both hardware and software.• Responsible for requirements and configuration management for various new and sustaining platforms. • Responsible for communication of technical and functional level requirements to various regions including India, Russia, China, and Japan. Provide R&D support to Field Service Engineers in US, Europe, and Japan.• Author, execute, and review Design Validation/Verification Protocols and Completion Reports.• Author and execute Change Controls, Deviation Waivers, etc. Audit DHF and traceability on variety of projects. Maintain Software Project Notebooks and participate in audits. • Work cross functionally within the organization including but not limited to, Medical, Marketing, Field Service/Product Support, Quality, R&D Microbiology/ Molecular, and R&D Engineering inclusive of Mechanical, Electrical, and Software. • Responsible for communications and leading efforts with external software engineering vendors and contractors to ensure validation requirements and standards are met.• Safety Manager of BSL2 Systems Engineering lab used for specimen manipulation and chemical usage in compliance with CDC guidelines; inclusive of Risk Assessments, Monthly Audits, Near Miss reports, and various monthly emphases as defined by the corporate safety department; ensure quality system compliance for instrument calibration.• Mentor and coach other associates and direct reports. Manage and resolve to associate/ resource issues.

• Lead software V&V efforts for molecular and microbiology instruments; participating in all project phases from defining requirements during Definition, leading test team to define technical specifications and test procedures, through test executions (directed, unit, integration, regression, system, and acceptance testing phases), product launch and field support.• Write and control software documentation for FDA and EU Submissions, inclusive of software deliverables, specifications, and test procedures. • Lead the test effort for the Remote Diagnostic software releases to the molecular and microbiology platforms.• Mitigate and troubleshoot various complaints and issues; participate in implementation of CAPA, FDA audits, customer complaints, etc. • Prepare and maintain project schedules for validation efforts.

• Writing, editing, and implementation of documentation including Test Cases and Specifications for medical laboratory instrumentation. • Contributor to several embedded software releases for the BACTEC blood culture product line and the EpiCenter Data Management System.

• Writing, editing, and revising SDLC documentation for GMP applications and equipment.• Documentation including: Validation Plans, System Design Specifications, Functional Requirement Specifications, User Requirement Specifications, Traceability Matrices, and IQ/OQ/PQ Validation Protocols.• Validation of computer maintenance management systems and equipment.• Execution of test scripts at customer facilities.• Electronic records, documentation, and signatures compliant with CFR 21 Part 11 Regulation.

• Designed internal Earned Value Management System (EVMS), budget analyses, costing and baseline for Autonomous Navigation System (ANS) Program, FFW program, and manned ground vehicles programs for Department of Defense.• Authoring, editing, revision, and implementing logistic plans consisting of: Supply Chain Management Plans, Performance Based Logistics Implementation Plans, Supportability Analyses and Life Cycle Cost Containment Plans and Estimates.• Attend Face-to-Face meetings to interface with government and prime.• Analyze preliminary design concepts and provide recommendations to provide additional versatility within the design, increased reliability and increased supportability.