Gary Lucas Email & Phone Number

Cleveland/Akron, Ohio Area

Responsible for implementing all field correction activity’s across all medical device product lines.• Product Safety Committee (PSC) Customer Support (CS) representative responsible for reviewing all required adverse events occurring in the field evaluating risk and harm to patients and/or operators. • Responsible for the creation and release of all project related CS activity’s for Field Change Order (FCO) deployment and reporting.• Maintain financial information for all FCO’s; provide FCO cost and completion status to the finance department along with support of company financial audits.• Provided FCO status and updates to senior management (future FCO releases, FCO progress, field escalation and country extension requests).• Chaired weekly meetings with field Modality Project Managers (MPM’s) and field representations to discuss any required field escalations for compliancy, discuss upcoming FCO’s releases along with gathering field feedback.

Cleveland/Akron, Ohio Area

• Responsible for providing technical Quality Assurance support and guidance for design transfer and production line quality activities.• Responsible for process validation, design/process changes, Change Record Board (CRB) representative, stop ship, risk and impact evaluation, root cause evaluation, correction and corrective action. Creation and closure of Quality Notification (QN’s), QN tracking and support.• Responsible for interdepartmental and cross-functional/organizational relationships to drive compliance to Quality System Requirements (QSR’s) and company procedures.• Determine proper disposition of any in house non-conforming material and nonconformance record.• Advance Molecular Imagine (AMI) Lead PQE for the successful Production Qualification (PQ)• Relaunch of an entire product line after a voluntary production shut down. This required updating and verifying all procedures and process. Trained production technicians on new processes.• Received green belt certification for leading a team assigned to review all shipped items along with the entire installation process for time / cost savings which resulted in a projected annuals saving of $535,000. Used DMAIC and Six Sigma LEAN processes to accomplish.

Cleveland/Akron, Ohio Area

• Responsible for investigating and reporting on adverse events that occurred with products in the field.• Ensure customer feedback / complaint review processes meet the requirements along with determining if the event required reporting depending on domestic and international laws of what country the event took place.• Drove improvements into the product performance by utilizing trends and data analysis derived from customer feedback database. • Assisted in all aspects of quality assurance and regulatory affairs.• Developed training material along with training all newly hired personnel.• Developed and conducted a Post Market Surveillance training class for 100+ field specialists.

Cleveland/Akron, Ohio Area

Responsible for resolving field issues for all Advanced Molecular Imaging (AMI) product lines.• Lead a $1.5M field safety issue. Coordinated the return of failed components, performed a root cause analysis. Involved with the development of the inspection and replacement process. Development of the procedure and replacement kit. Responsible for gathering all field-returned inspection documents (900+) while maintaining a completion database and also managed initial stock allocation. Provided weekly status reports to senior management• Developed and maintained a Web based Newsletter process used to quickly convey information from the Business Unit to over 500 worldwide field service engineers supporting all NM products. • Developed and maintained detailed pre-wiring drawings for all NM systems used to assist FSE’s properly run all required wiring during system installation. This resulted in a 4 hour installation time reduction for all installs.• Involved with development of a floor leveling process which improved the quality of the process and also reduced time and cost which became the standard pre-pour process for all products.