Every day I get to work with the greatest team ever assembled on Quality and Regulatory improvements at Northgate Technologies. WE: Facilitate FDA Inspections. Lead Northgate through Quality System upgrades including ISO 13485:2016, and MDSAP certification. Ensure compliance of products to upgraded standards and regulations including MDD Upgrades (including Annex X - update of Clinical Evaluations), 60601-1, 3rd Edition, First Amendment, and 60601-1-2 4th Edition. Create, and oversee Regulatory Intelligence program within Northgate leadership group and team including involvement on pertinent standards at a US Technical Advisory Group level, as well as participation at an international level. Lead business development with OEM partners' Regulatory Affairs to facilitate regulatory approval around the world. Working toward updated EU MDR updates to Quality System to support continued compliance.TEAM ACCOMPLISHMENTS: * Transition to ISO 13485:2016, and MDSAP Certification * Transition from Paper QMS to eQMS including Documents and Training during COVID * 510(k) Approvals: * NEBULAE SRS Smoke Removal System (K202944) * URO-TOUCH 9 French Electo-hydraulic Lithotripsy Probe (K202813) * Manage Product Recalls from initiation to termination

Manager responsible for CAPA and Non-Conformances for the Plant, and global product quality. Talent Management of up to 3 Quality Professionals. Managed Non-Conforming Materials – ensuring timely disposition of critical components, kits, and devices manufactured at the plant, as well as incoming materials, including product distributed to affiliate warehouses globally. Created and managed proactive metric for managing Non-Conforming Material based upon criticality to operations. Managed trending for Non-Conforming Material resulting in identification of need for more robust process controls in plant. Participated on global working team to implement guidance for best practices in trending globally. Team responsible for reduction in Containments from 120 down to 19 (Work in Process), improvement in Turn-around-time from 200 days, to less than 50. Dollars in contained inventory dropped from greater than $2.5MM in 2015 to $695M in March of 2017. Led cross-functional team effort to reduce non-conformances in the plant from 71.8 NC/kWO average in 2015 to 38.1 NC/kWO in March of 2017. Managed CAPA Review, including chairing CAPA Review Board consisting of cross-functional team of Operations, Quality, and Engineering (Technical Support). Managed timeliness metrics for CAPA including 100% on-time investigations. Divisional lead on Global CAPA/MRB system (TrackWise) implementation, including defining work-flow, and requirements across Abbott. Project in-process on-time and on-track for delivery in 4th quarter 2017.

Quality Manager for Sustaining Products Quality Engineering. Additional responsibilities to Complaints and Investigations (Previous Position) including Sustaining products support. Quality Engineering Representative at Product Change Control Board (CCB), and Product CAPA Review Board (pCRB). Implemented, and managed CAPA Process via Visual Management - Daily Stand-ups which increased efficiencies, and leveraged learnings across CAPA Teams (including Renal Hardware). Manage team consisting of Complaints and Investigation team (2 Supervisors, 8 Quality Engineerss), and Product Support (3 Senior Quality Engineers) including Talent Selection, and Development.

Manager responsible for Complaints and Investigations group for Global Infusion Systems/Medical Devices at Baxter. Group consists of 11 full-time, and 12 contract positions including 21 Quality Engineers (9 full-time, 12 contract), and 2 supervisors. Manage, review, and construct development and career paths for employees. Development of strategy for conversion from specific product support to Medical Devices (specifically combining Global Infusion Systems and Renal to Medical Devices Division) Sustaining product support. This includes planning for re-structuring, talent selection and hiring of open positions (Contract and Permanent). Currently working with Global Field Surveillance, and Global Technical Service to manage complaint load, and ensure investigations are complete for evaluation, analysis, and reporting to FDA (where applicable).

Manager responsible for Quality and Regulatory functions at Des Plaines facility including Document and Quality Control; CAPA Coordination, International Registrations, Internal audits, external audits (ISO, FDA, UL, etc.), Quality Engineering and Assurance, calibration and final verification and validation testing. Talent Management of team consisting of 17 associates, support staff, and contract employees.

Managed Quality Engineers toward systemic, quality system improvements, and support of production. Supported successful FDA audit without any findings. Supported implementation of Supplier Management program. Managed turn-over within team, and with direct manager. Supported R&D in launch of 2 new products, and improvement in design control system. Audit Coordinator January 2009 - December 2010. Managed Final Verification and Validation Lab December 2009 - December 2010. Undertook acting QA/RA Site Manager position when previous manager left unexpectedly from January 2010 - March 2010.

Worked toward Quality Systems improvement. This included: Implementation of process monitoring (Process Flow, FMEA, Control Plans), SPC (including a successful implementation of InfinityQS), and Oracle ERP Enterprise Management.

Used previously described IMS development tools, and Project Management skills to manage Power Lift Cot (Power-Pro XT), and advance Power Load Projects from prototype through production. Executed patent authoring process on Power Lift including interfaces with Power Load system.

Developed and used Quality tools related to New Product Development. Position culminated in re-design of the product development system at Stryker (Project Invent it, Make it, Sell It (IMS)). Specifically, I was responsible for a Design Input Tracking to identify and track user needs through FDA Required stages - Input, Output, Review, Verification, and Validation. Led VOC, and Verification teams in this regard. Recognized as MVP of IMS.

Managed Quality for Bed group (Intensive Care and Med-Surg) resulting in improvement of reliability through systematic improvements in production, and inspection. Managed 2 technicians, and one quality clerk.

Began, and Managed Electrical Department, developing specialized capability to repair Endoscopic Cameras, Arthroscopic Shavers, Electro-surgical Units, and other medical devices. Managed inventory, monitored quality, dealt with suppliers, and managed one technician

As Electrical Engineer, designed Electro-surgical and Electro-therapy equipment, including ESU 120 ENT Digital (see website). Developed initial website for Elmed, including published articles, and sales brochures. Built Endo-scopes, and designed Electro-surgical Instruments. Managed projects in Urology, and surgical tables and chairs.