Set quality policy and strategic direction aligned with corporate goals as management representative and executive team member enabling a DeNovo clearance for a first-in-world device.

Created and implemented a customized, scalable Quality Management System (QMS) to enable design and development activities, 510(k) clearance, an Investigational Device Exemption (IDE) study, and the commercialization launch of a new medical device.

Director of Quality Assurance who planned and directed the implementation and maintenance of robust quality and business processes, ensuring the delivery of high-quality products in compliance with domestic and international standards. Hansen was a start-up focused robotic platforms used for controlling catheter-based technologies used in electrophysiology procedures and for navigation in the peripheral vasculature.

Multi-site cross-divisional management representative driving QMS integrations, product launches, and product transfers for acquisitions by driving strategic quality planning and execution activities, ensuring regulatory compliance, all while bridging complex cultural gaps with intercompany personnel.Acquisitions:•Asthmatx, a $250M acquisition Endoscopy-Pulmonary division, for the PMA cleared Alair™ Bronchial Thermoplasty (BT) System for treating severe asthma using RF energy to ablate smooth airway muscle. Led quality post-acquisition integration activities which included leadership during two FDA inspections. Also provided clinical quality support for a three-hundred subject, five-year, FDA post- approval study.•Rhythmia Medical, a $175M acquisition within the Electrophysiology division. Led the quality team through limited market release and full commercial launch of the next generation 510(k) Rhythmia HDx™ Heart Mapping System and Intellamap Orion™ 3D mapping catheter in the US and EU markets.•IOGYN, a $65M acquisition within the Urology and Women’s Health division. Supported limited US market release and full commercial launch of the Symphion™ System, a 510(k) cleared device for resection of uterine tissue using RF energy for cutting and a unique fluid filtering system.Boston Scientific Site:•Site Head of Quality for BSC manufacturing, distribution and customer service center. Provided quality leadership and was site leadership team member. Interfaced with BSC corporate, divisional leadership, manufacturing plants, sterilization facilities and external suppliers and contract manufacturers.

Managed activities in support of product inspection and release for all commercially distributed products. Liaison between distribution, manufacturing and corporate supply chain ensuring priorities are met and product is released according to requirements.

Set policy, provided quality leadership and lead implementation of site level quality initiatives meeting CFR Part 820, 210, 211, ISO 13485, 14001, 14971, cGMP’s requirements. Fostered relationships with corporate and site level executive leadership ensuring appropriate management controls were implemented for and manufacturing and distribution environments.

Managed capital projects and all associated activities including design, development, testing, validation, training, and maintenance of systems in support of regulated lean manufacturing operations for both process flow and job shop environments.

Generated optimal business results by utilizing people, materials, and machine processes within a regulated GMP CNC machining department across three shifts.

Directed plant wide manufacturing activities within a highly flexible, fast paced, multi shift, 100-employee operation including Production Planning, Quality Assurance, and Production Support. Implemented and maintained ISO 9001 CAPA/NCR Program.

Directed operations and quality organizations meeting production schedules while challenging standards through utilization of people, materials, and process.

Oversaw four production departments meeting production schedules while maintaining standards to ensure on time delivery of quality goods in the required volumes.