Jesse Shearin Email & Phone Number

Atlanta, Ga, Us

Atlanta, Georgia, United States

Interfaces with global regulators and notified bodies.Responsible for maintenance and renewal of global QMS certificates.Manages the global audit program and QMS certification budget.Reports Audit results quarterly to Siemens Healthineers Head of Regulatory Affairs and Standards.Owns the Monitoring and Measurement of Quality.Streamlining Management Review process.Re-organizing invoicing of QMS-related services.Drives enhancements to the electronic audit tool.

Atlanta, Georgia, United States

-Responsible for executing and managing the Global Audit program, including medical device regulatory body inspections and internal audit program. -Build and maintain multi-year audit plan to maintain certifications and ensure coverage of key functions.-Train and mentor internal auditors and share best practices from all global internal and external audits to ensure the quality system is robust and effective.-Revamped audit program to efficiently utilize remote auditing technologies where possible, thereby reducing hours and resources lost to travel and increasing safety of auditors.-Managed project to align current company policies with governance directives of new parent company with after acquisition by Siemens Healthineers.-Participated in IQ,OQ,&PQ validation of new part 11 and Annex XI compliant cloud-based electronic auditing module tailored to MDSAP auditing process.

Atlanta, Georgia, United States

Atlanta, Georgia

I have always wanted to the work within the field of Oncology, and joining Varian Medical Systems affords me an opportunity to help create innovative cancer treatment tools. My role is to manage and maintain quality system components specific to the Velocity group at Varian and to interface with the broader Varian quality and regulatory groups. Whether developing, implementing, and maintaining the quality system and control systems, performing internal and external quality audits, providing quality assurance support to software development projects through CAPA, complaint handling, and QMS documentation, or participating in the software engineering design reviews to contribute quality requirements and considerations, my focus remains on positive patient outcomes. To facilitate success, I assist product support areas in gathering and analyzing data, including risk management information; implement company policies, programs, and guidelines; ensure employee productivity and growth; and maintain the functional, technical, and external market awareness necessary for managing the local organization. I enjoy overseeing the local regulatory activities and strive to share my expertise in translating regulatory requirements into practical, workable plans. Periodically, I get to interact with regulatory agencies and hosts audits when not supporting timely preparation of organized and scientifically valid applications for country registrations. Working with extremely talented and passionate cross-functional teams to bring innovative cancer treatment tools to market delivers meaningful gratification.

Greater Atlanta Area

As team leader I ensure my team has the critical resources to provide excellent service to customers through preparation and execution of certification and compliance audits. Assisting medical device manufacturers to drive continuous improvement of their Quality Management Systems to create innovative and meaningful enhancements to patient health is of great importance.

1775 Old Hwy 8 Nw Ste. 104 New Brighton, Mn 55112 Usa Operating Out Of Atlanta

Duluth, Georgia

Test medical products for compliance to relevant standards based on intended market, audit risk management files, specialist in IEC60601-11 Home Healthcare environment and IEC60601-1-8 Alarms testing.Generate findings to assist clients throughout the listing process.At Intertek I conduct safety, performance, and compliance testing to country-specific national deviations for worldwide product launch. I assess existing and novel medical devices for compliance to the relevant standard(s) and produce test reports that clients take to regulatory bodies such as FDA, CFDA, European Commission, and PMDA. The most common standards applied to medical devices are IEC 60601-1 2nd edition, IEC 60601-1 3rd edition, IEC 60601-1-6 Usability, IEC 60601-1-8 Alarms, and IEC 60601-1-11 Home Healthcare. Devices that rely on software for freedom from harm, basic safety, or essential performance require Programmable Electrical Medical Systems (PEMS) Validation. If a product is rated for a certain degree of ingress protection, tests according to IEC 60529 Degree of Ingress Protection for Enclosures are applied. Applied particular standards including thermally protected motors, medical beds, stretchers, surgical tables, surgical luminaires, blood-glucose monitors, respirators, lung ventilators, high-frequency medical equipment, nerve and muscle stimulators. Frequently, desktop audits are performed to show compliance with ISO 13485 Quality Management Systems, ISO 14971 Risk Management for Medical Devices, IEC 62366 Application of Usability Engineering to Medical Devices, and IEC 60445 Basic and safety principles for man-machine interface, marking, and identification.By focusing on customer needs first and communicating directly with clients, I am able to provide quick turnaround times for clients whose greatest need is speed to market

Kaufbeuren, Germany

Temporary, 3-month assignment at Intertek Germany to assist with backlog to ensure client medical device certification deadlines were met. While on site, I trained junior engineers; increased Technical Sales and Sales Engineering skills; exchanged best practices and technical information with local staff; interfaced with local Global Key Account client; and gained valuable international business experience.

I assist high school juniors and seniors with SAT and ACT prep, as well as tutor them in a variety of Subject Tests including Statistics, Physics, Algebra, Pre-Calculus, Calculus, Biology, and overall study skills.

Tutored Physics I & II, Inorganic & Organic Chemistry, Linear Algebra, and Calculus I, II, & III, Statics Received `Outstanding Tutor' Award for 2008

Tutored Algebra, Trigonometry, Calculus I & II, and Differential Equations

Responsible for inventory control in distribution plant, tracking down lost pieces, and processing orders in a timely manner

Bs, Biomedical Engineering

Activities and Societies: Learning Assistance Program Tutor Biomedical Engineering Society

Bachelor Of Science, Biomedical Engineering

Activities and Societies: Georgia Tech Biomedical Engineering Society

Bs, Biomedical Engineering

Activities and Societies: Learning Center Tutor for Physics I&II, Calculus I, II, & III, Statistics, Chemistry I & II, Biochemistry.

Regent'S, Engineering Transfer Program; Mathematics And Physics