+1 401.216.9053
Rick Smith
Strategic Leadership & Consulting
+1 401.216.9053
rick@smithqualitysolutions.com
Northborough, MA 01532
Hello! I'm Rick
I am an experienced multi-functional leader and operator across a broad range of technologies. Having worked in CT imaging, diagnostics, surgical devices, implantables, robotics and drug delivery devices in small-sized companies has required adapting knowledge to new situations and applying it to new challenges.
Five years as an officer in the US Navy's nuclear submarine force gave me a solid technical and leadership foundation for entry to industry in 1999. I then progressed through roles in quality, regulatory affairs, operations and strategy while also picking up responsibility in areas such as: product development, pre-clinical and clinical affairs.
EXPERIENCE
2025 - 2026
Sr. Manager, Ops Quality
Revvity
- Site Quality Lead responsible for all aspects of Quality.
2023 - 2025
Director, Quality
Guardian Agriculture
- Managed QC, Design Assurance, and QMS for unmanned aircraft.
- Handled Arena PLM controls, ECO processes, incoming inspections, manufacturing documentation, and MES implementation projects.
2018 - 2022
Senior Vice President
Portal Instruments
- Defined strategic roadmaps and oversaw multi-functional operations.
- Spearheaded the creation of human clinical prototypes and nurtured high-level alliance partner relationships.
2014 - 2018
Sr. Director, QA/RA
BionX
- Modernized quality systems to launch redesigned products.
- Enabled successful market entry and acquisition, overseeing the subsequent integration of technical operations.
2011 - 2014
Director, Quality
ConforMIS
- Directed global quality for permanent implants.
- Supervised a team of 20
- Successfully led the organization through rigorous FDA inspections and ISO certification audits.
2005 - 2011
Director, Quality
Hologic
- Managed Quality Engineering functions for complex devices
- Responsible for PMA filings and regulatory strategy
- Reconstructed core Quality Management System components to enhance both regulatory compliance and organizational speed.
Education
Worcester Polytechnic Institute (WPI)
BS - Physics | 1990 - 1994
Major Qualifying Project: Used Quasi-Elastic Light Scattering Spectroscopy (QELSS) for molecular analysis. Awarded for academic and research excellence; member of Sigma Pi Sigma and Tau Beta Pi honor societies.
US Navy - Nuclear Power School / Prototype
Naval Nuclear Officer | 1994 - 1995
Graduate-level coursework in Mathematics, Physics, Chemistry, and Engineering. Qualified to supervise naval nuclear reactor operations.
US Navy - Nuclear Engineering Officer School
Nuclear Engineering Officer | 1998
Studied the theory, design, and operating parameters of Naval nuclear plants. Successfully completed intensive technical examinations at the Naval Reactors organization in Washington, D.C.
PUBLICATIONS
Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform
PDA Journal of Pharmaceutical Science and Technology, March 2022
Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system
Drug Delivery, December 2021
Aggregation Number and Hydrodynamic Hydration Levels of Brij-35 Micelles from Optical Probe Studies
Langmuir 1995 11 (9), 3408-3416.
Core Experience
Strategic Planning
Operations Management
Quality Management
Product Development
Cross-functional Leadership
Alliance Management
Regulatory Affairs
Device & Combination Product
Clinical Operations
EXPERTISE
Executive Leadership
Assist senior leadership teams in defining and maintaining a holistic view of the organization and the internal systems that support it. Work to establish a long term strategy and actionable objectives.
Operations Management
Drive establishment of essential internal systems, processes, and infrastructure to support the organization through strategic scaling, while carefully managing growth costs and trade-offs.
Quality Management
Manage all aspects of Quality in small organizations, establishing and maintaining quality management systems (QMS) that are precisely aligned with the company’s specific lifecycle stages.
Soft Robotics
Portal Instruments
ConforMIS
First Light Bio
CLIENTS
Freedom Innovations
BionX | Ottobock
Hologic
Vapotherm
Let's Chat!
+1 401.216.9053
rick@smithqualitysolutions.com
Northborough, MA 01532