David Appleton Email & Phone Number

Privileged to lead global Quality, including building an integrated quality organization under APTYX. At Apytx, making it happen is the way we do business. It takes an unwavering focus on quality. It takes deep expertise in engineering and know-how in molding, extrusion, coatings, and assembly. It takes integrity in action and a growth mindset: always being on the lookout for what’s possible. We believe in a collaborative approach to complex manufacturing because we know our success depends on our customers’ success. We do it because the products we make matter.

Rock Hill, Sc

Expanded responsibilities include global QMS oversight of QSR, a leading producer of high precision automotive insulators and connector seals, along with continued QMS oversight of all North American Qure Medical manufacturing sites.

Rock Hill, Sc

Qure Medical December 2018 – September 2019Qure Medical provides high quality, value-added, integrated elastomeric solutions to medical device manufacturers while meeting the stringent standards of the healthcare industry. These industry leaders rely on Qure’s unmatched suite of development and production capabilities for the components that help them make perfect devices.Director, Quality Assurance & Regulatory AffairsQure Medical, North America December 2018 – PresentResponsible for all Quality System, Environmental System and Regulatory functions, including compliance to ISO 13485:2016, ISO 14001 and 21 CFR Part 820 for manufacturing sites in SC, OH and WI. Regulatory responsibilities focused on establishing and maintaining medical device registrations, biocompatibility clearances (Drug Master Files) and material/environmental compliance certifications. Continuous improvement activities include implementation of lean and six sigma processes, along with hosting of kaizen events for 5S and waste reduction. Quality Staff Manager, Qure Medical – Rock Hill SC May – December 2018Management responsibilities include effective implementation of the ISO certified Quality Management System, environmental compliance, personnel management and development, as well as technical and administrative management the of Material and Metrology Laboratories.

Charlotte, North Carolina Area

Continue to provide personnel and QMS management for multi-site Dental Technology Operating Companies in North America, including continuous improvement Quality System activities for the central manufacturing site headquartered in Charlotte, NC. Serve as Management Representative including preparation and presentation of periodic Management Reviews, management of the CAPA and Internal Audit systems, and provision of guidance and technical direction for reliability improvement projects.• Established MDSAP certification in 2017 for Charlotte, NC manufacturing site• Currently updating multi-site QMS’s for ISO 13485:2016 certification in 2018• Facilitating activities to achieve global QMS harmonization for Dental Technology OpCo’s located in North America, South America and Europe• Continuing activities to achieve paperless QMS record system in 2018

Hatfield, Pa

Responsible for effective and efficient implementation of the Quality Management System for Class I and Class II medical devices. Also responsible for management oversight of global product registrations, regulatory compliance initiatives, and cross-functional support of new product development.

Hatfield, Pa

Hatfield, Pa

Hatfield, Pa

King Of Prussia, Pa

As Quality Manager, responsible for the deployment of a Quality System for highly automated manufacturing equipment for Class I medical devices. This includes validation of converting and packaging equipment, and verification of all critical control points inherent to the QMS. Also responsible for highly standardized GMP systems in place including Part 11 compliant electronic documentation of the Device Master Record and Device History Record, as well as all Quality Assurance functions for Risk Management, CAPA, Incoming raw materials, laboratory systems including equipment calibration, non-conforming product, finished product release and post-market surveillance.

Telford, Pa

As the Senior Quality Manager, was responsible for overseeing product verification testing and reporting for 510 (k) submissions of Class II medical devices, including lab management and QMS deployment to maintain ISO 13485 compliance. Responsibilities included a high degree of interaction with all departments as well as direct contact with the FDA. Also actively participated on ASTM and ISO Technical committees for Respiratory Devices and Equipment used for General Anesthesia.

Bachelor Of Science, Electrical Engineering

Activities and Societies: National Key Honor Society

Specialized Coursework In Reliability Engineering