Director, Quality Management and Regulatory Affairs (QMRA)Developed and implemented the FDA Part 820 and ISO 13485:2016 compliant QMS (Quality Management System), which has successfully been supporting and enabling robust, compliant growth, leading to a 30% revenue growth in 2021 over 2020.Built a 3rd Party Sourcing and Business Development Process which significantly increased FDA/ISO compliant sourcing and revenue from 3rd Party vendors, including Private Label products. Developed and implementing a full scope RMS (Regulatory Management System) with 510 (k) submissions and expansion into new markets

Developed and directed industry leading Quality Department at DSM’s medical device plant, consisting of QC, Supplier Quality Assurance, Quality Engineering, Quality Systems and Compliance, Sterilization, and Quality Process Engineering functions. • Built solid, robust FDA Part 820 compliant and ISO 13485:2016 and MDSAP certified QMS with zero findings from most customer / Notified Body audits in 2019. • Created first-rate Supplier Quality Assurance (SQA)Team, performing supplier audits, segmentation, selection, qualification, management and improvement, mitigating risk of potential supply disruptions. • Gained recognition from top 5 major medical device companies for approach of rolling out Customer Centric Quality organization where Quality Engineers are paired with major customers and serve as central resource in addressing quality issues. • Developed and implemented roadmap rolling out SPC / process capability management for incoming and finished goods testing that will significantly reduce testing and cost.• Implemented operational, validated LIMS-system in Exton on schedule, utilized for driving test reduction in QC and providing data in real time, fostering faster decision making and automating generation of COAs / COCs.• Created monthly reporting on QMS activities not previously reported, including quantity of Engineering Change Notifications, CAPA time to closure, Deviation & NCR quantities, and on-time performance of all tasks.• Worked cross-functionally with Operations in developing and implementing time savings / cost savings strategy, achieving testing cost reduction of >$80K in 2019, expanding approach to 5 other major customers in 2020 with expected savings of approximately $200K. • Reduced unnecessary testing by removing "For Information Only testing”, identifying types that "never fail", and eliminating redundancy found on supplier CoA with savings of over $30K in 2019.• Internalized outsourced testing, achieving savings of 50K in 2019.

Directed and implemented the quality and FDA regulatory compliance strategy for Linde North America, a medical device, pharmaceutical drug gas and respiratory solutions, food gas, and industrial atmospheric gas company. Linde has plants in the US, Canada, and Puerto Rico, with affiliate facilities across the globe.• Streamlined and successfully integrated geographically dispersed quality and regulatory functions into one cohesive Quality Department. Achieved significant synergies and enabled the company to charge a quality based premium for its medical and beverage products, while simultaneously driving continual improvement in medical device and medical gas compliance.• Initiated a methodical approach to analyze plant data by implementing inferential and predictive statistical tools that drove continual improvement in process and product variability.• Consolidated 9 informal, separate complaint processes into one integrated, computer based online system. Automated pharmaceutical Adverse Event and Medical Device Reporting (MDR) processes.• Conceived and formalized a robust product recall process that enabled easy identification and correction of traceability issues based on mock recall drills and fully achieving FDA compliance.• Planned, developed and implemented the quality process for ISO 9001:2000 Certification at the company’s manufacturing plants. Significantly reduced the amount of customer impacted non-conformances and achieved no major ISO 9001:2000 findings in six years at BOC/Linde.• Coordinated and led a gap and risk assessment team which identified and addressed the major medical gas and medical device CGMP compliance risk issues at plants acquired in a merger with no citations issued to any of these sites in recent inspections.• Developed and implemented a process for effectively managing FDA, In-State, and Out-of-State drug manufacturer and wholesale distributors’ registrations and licenses resulting in 0 citations or fines.

[Concurrent Linde Leadership role with Compressed Gases Association (CGA), an industry association]Vice-Chairman/Acting Chairman – CGA’s Medical Gas Regulatory Policy Comm. (MGRP) 2007 - 2009Elected by industry experts and peers to key leadership role as Vice-Chairman/Acting Chairman of the MGRP, the medical gas industry-wide coalition that regularly interfaces with FDA on medical device and drug regulations. • Facilitated and played a leading role in the development and implementation of the MGRP’s strategic and communication plans which led to increased collaboration with regulatory agencies such as FDA, state agencies for pharmaceuticals and medical devices, National Board of Pharmacy, and USP.• Official liaison that inspired and elevated cooperation between the medical committees of the CGA and the European Industrial Gas Association (EIGA), ensuring a more unified collaborative approach in response to FDA and European pharmaceutical regulatory initiatives. Achieved better harmonized cross-border Linde and industry positions.• Spearheaded Linde and industry efforts to develop and implement new medical regulatory standards that have led to 0 fatality or serious injury adverse events from CGMP issues in recent years.

Directed the Safety, Health, Environment, and Quality (SHEQ) Department for the ISP Division of BOC. Charged with developing and implementing the SHEQ strategy across the US and Canada.• Instituted comprehensive CGMP quality programs at the Division’s manufacturing plants. Recognized as best in class for improved pharmaceutical regulatory compliance, reducing the number of 483 findings from 8 to 1.• Introduced team to a new safety statistics reporting process which used regression analysis to project safety incident trends and targeted initiatives against major injury categories. • Directed the successful ISO 9001:2000 process at the Division’s plants with no major ISO 9001 findings and with significant continual improvement in the quality process.

Directed and implemented the corporate Safety, Health, Environment, and Quality (SHEQ) strategy across the US and Canada at Agfa, the medical devices, chemicals, and imaging company.• Devised a vision with clear goals and objectives which promoted business growth and achieved continual improvement in regulatory compliance to CGMPs, OSHA 1910, RCRA, SARA, Clean Air Act, Clean Water Act, TSCA, EPCRA, and SPCC.• Instituted process improvements that reduced total recordable incidents and lost workday cases by 20% and 12%, respectively, in two years.• Enhanced organizational efficiencies resulting in decreased headcount by 60% over two years while driving improved manufacturing regulatory compliance and services to both internal and external customers. • Reengineered multi-plant Continual Improvement Quality Process, based on TQM and Six Sigma, that led to $20 Million cost savings.Progressed through a series of positions of increasing responsibility at Agfa, Div. of Bayer: worked as a research scientist, applications scientist, operations process controller/quality engineering manager, manufacturing manager, analytical laboratory manager, and QC/QA manager.