Jonathan Stevens Email & Phone Number

Bothell, Washington, US

Reporting to the President and CEO, responsible for all aspects of Quality & Regulatory globally including Design, Regulatory Affairs, Clinical Evaluations, Manufacturing, Quality Systems, Distribution, Supplier Quality, Post Market Surveillance, and Technical Communications.Lead, develop, and coach over 60 highly skilled Q&R professionals globally.

Amsterdam, Noord-Holland, NL

-Head of Quality for the Hospital Patient Monitoring business, serving nearly 600 million patients annually generating $2B+ revenue. -Responsible for all aspects of quality and compliance globally including design quality assurance, risk management, CAPA, post market surveillance, quality management systems, internal and external audit, and corrections &.

Amsterdam, Noord-Holland, NL

-All responsibilities of the previous role plus:-Responsible for the Quality Engineering function supporting the entire product lifecycle, including product development, launch, regulatory submissions, and maintenance. -Led capability enhancements including taking ownership of several DHF and Risk Management deliverables, resulting in increased partnership.

Amsterdam, Noord-Holland, NL

-Responsible for teams carrying out FDA Consent Decree and EU MDR post market surveillance remediation.-Created and deployed updates to risk management for EU MDR compliance, including creation of Post Market Surveillance Plans, PMSR, and PSUR reports. -Responsible for the data analysis team.

Amsterdam, Noord-Holland, NL

-Developed new post market surveillance processes that are lean and compliant for Consent Decree and EU MDR remediation. -Partnered with peers in other Philips business groups and central teams to generate best practices in metrics, risk evaluations, and quality plans.

Minneapolis, MN, US

-Responsible for end-to-end risk management, standards compliance, and field corrective actions.-Implemented a framework for linking complaints with risk management, signals detection, and design, which drove continuous product improvement via dozens of CAPAs. -Led multiple global recalls affecting tens of millions of units and millions of customers..

Auckland, NZ

-Drove improved design of over 12 next generation products using new analytical methods and positive influence. This resulted in up to an 80% reduction in customer complaints, a 20% reduction in supplier and manufacturing non-conformances, and decreased regulatory submission times by several weeks. -Responsible for risk evaluation HHE and execution of.

Auckland, NZ

-Created a company-wide culture that utilizes post market data to design out potential issues.-Led the team responsible for global complaint handling, servicing, vigilance / MDR adverse event reporting, health hazard risk evaluations, and field corrective actions. -Drove continuous improvement by establishing positive rapport and influencing executive.

Auckland, NZ

-Lead Quality support for multiple manufacturing lines producing several hundred thousand devices per year for respiratory and acute care therapies. -Supported risk management activities including design transfer, test method validation, process validation, statistical analysis and process control, leading to several dozen successful new product.

Auckland, NZ

-Led cross-functional teams to engineer solutions through testing, verification and validation, supplier part changes, and production line expansions. -Implemented a Lean culture where every employee is empowered to Pull the Andon for quality.

Dublin, Coolock, IE

Collaborated with scientists and management to draft new drug studies, leading to five successful FDA New Drug Applications that progressed into FDA approved and marketed drugs.

Masters, Business Administration

Bachelor Of Science (B.S.), Biomedical Engineering